June 2013 D1018 Rev.G p. 1

Treatment Guidelines

For United States Customers Only

Cutera Inc. World Headquarters 3240 Bayshore Boulevard, Brisbane, CA 94005 USA

Tel: +1 415 657 5500 Fax: +1 415 330 2444

www.cutera.com

The following treatment parameters were created for the GenesisPlus unit ONLY and are not to be used for the Nd:YAG on the Xeo, CoolGlide or ExcelV systems.

June 2013 D1018 Rev.G p. 2

The Cutera GenesisPlus is an Nd:YAG (1064nm) laser with a patented pulse structure designed for safe and effective treatment on all skin types and tanned skin. It can be safely used on all body parts (excluding the eye and surrounding area). Common indications include:

Temporary increase of clear nail in patients with Onychomycosis / Nail Fungus Warts Scar reduction: including reduction in hypertrophic and keloid scars Treatment of wrinkles Rosacea / Diffuse Redness Poikiloderma of Civatte

PREREQUISITE

The GenesisPlus device should only be operated by qualified practitioners who have received appropriate training and have thoroughly read the GenesisPlus Operator Manual (shipped with laser) and reviewed the GenesisPlus Training Presentation (found on Cutera VIP website) prior to operating the laser.

PATIENT ASSESSMENT This is a medical device. It is important to obtain a complete medical history and signed informed consent. Consult the Operator Manual for additional information, including expected transient events and possible adverse events. Determine ethnicity and skin type by using the attached Fitzpatrick Skin Type scale Contraindications: Pregnancy and patients undergoing treatment for skin cancer Patient Considerations including but not limited to are below:

Current Medications (both routine and occasional use) o Accutane – do not treat if taken in the last 6 months o Gold Therapy – may cause blue-gray discoloration o Anticoagulants – may increase risk of purpura or bruising

Vitiligo – may cause de-pigmentation Herpes – pre-treatment with an antiviral may be indicated Open wounds Diabetes – may impede wound healing Neuropathies – decreased sensation or numbness

o Treatment area should be evaluated for numbness or decreased sensation History of keloid or hypertrophic scarring Tan skin and darker skin types have an increased risk of complications and/or pigmentary issues. Parameters may

need to be adjusted to help prevent adverse events. No self-tanners, spray tans, etc. for at least 2-4 weeks prior to treatment Do not treat questionable skin lesions. These should be evaluated by a specialist prior to treatment.

o Online Melanoma resources include (www.aad.org), (www.cancer.org)

June 2013 D1018 Rev.G p. 3

Visible aiming beam

Visible working distance beam

Invisible Temperature

sensor

TEMPERATURE MONITORING

GenesisPlus features a temperature sensor which monitors average temperature over a larger treatment area when handpiece is approximately 4cm from the tissue

The temperature in Celsius will be displayed on the screen with the colored lights on the handpiece corresponding to that temperature

Can be used as an indicator of bulk heating o Bulk heating is usually achieved at 39-46 o C (Yellow LEDs)

POSITIONING THE HANDPIECE

When performing treatments, position the handpiece approximately 4cm above the treatment area maintaining that distance during the entire treatment

Ensure that the smaller working distance beam is centered in the larger aiming beam

The temperature sensor will not be visible

GOGGLES

Safety eyewear must be worn by ALL people in the treatment room. o Check the wavelength and optical density (>=6.1 @

1064nm) marked on all operator goggles o Patients can opt to wear Operator Goggles during off the face treatments

SELECTING PARAMETERS The recommended parameters are provided as a guide and are based on practitioner feedback.

Fluence is the energy measured in J/cm2 o Fluence may need to be lowered for areas with increased target

Pulse Duration or Pulse Width is the length of each laser pulse measured in milliseconds (ms)

o Shorten pulse duration for more aggressive treatments o Lengthen pulse duration for more conservative treatments

Repetition Rate is the number of pulses per second measured in Hz o Repetition rate may need to be lowered for increased patient comfort

LED Color Temp Range

Green 26-30 o C Green 31-34 o C Green 35-38 o C Yellow 39-42 o C Yellow 43-46 o C Red 47-50 o C

Operator Goggles Patient Goggles

June 2013 D1018 Rev.G p. 4

TEMPORARY INCREASE OF CLEAR NAIL IN PATIENTS WITH ONYCHOMYCOSIS/ NAIL FUNGUS – PERFORMING THE PROCEDURE

5 mm Spot Size Podiatry Setting

Avoiding Complications Anesthetics or nerve blocks are not recommended as patient feedback is required Patients with neuropathy may not be able to provide feedback

o Increased risk of adverse events Do not treat over or close to tattoos Implants

o Reaction to metal implants is unknown o Pacemaker - stay at least 6 inches away from implant

Prepping the Patient Remove nail polish and clean toes/fingers Remove or cover any jewelry (including toe rings) Clean all nails thoroughly Shave the treatment area if there is excessive hair Topical anesthetic should not be used as patient feedback is required If nail is thicker than 2mm, the nail may be debrided

o Smoke evacuator & laser plume mask filtered to 0.1 microns are recommended when debriding Nail may be notched with a file to assess growth of clear nail Pre-treatment photographs should be taken prior to the initial treatment for future reference Safety eyewear must be worn by ALL people in the treatment room Recommend that laser operator follow Universal Precautions (gloves, masks, etc.) Smoke Evacuator and/or laser plume masks filtered to 0.1 microns are optional during laser treatment

Selecting Treatment Parameters Start with slow repetition rate for patient comfort and adjust to patient tolerance

Spot Size Skin Type Fluence Pulse

DurationRepetition

Rate #

Treatments

5mm I-IV 14-18 J/cm2 0.3 ms 2 – 3 Hz 1-5

V-VI 12-16 J/cm2 0.3 ms 2 – 3 Hz 1-5

May need additional pulses for severely infected or larger nails.

Target Minimum Total Pulses Hallux/Thumb Toes/Fingers

Toes 1,000+ per foot 600+ 100+ per toe

Fingers 1,200+ per hand 400+ 200+ per finger

400+ pulses using multiple passes

200+ pulses per finger using multiple passes

600+ pulses using multiple passes

100+ pulses per toe using multiple passes

June 2013 D1018 Rev.G p. 5

Performing the Treatment

Gel is not used Nerve blocks are not recommended as patient feedback is required Treat the entire nail bed, matrix and lateral folds, extending approximately 2mm

past the nail Hold the handpiece perpendicular to the nail’s surface

o Ensure the distance beam is centered in the aiming beam (approximately 3-4 cm from target)

Treatment Technique: o Pulses should be adjacent with a slight overlap

Adjacent pulses should be of the larger aiming beam, NOT the smaller distance beam

o Do not stack pulses (one pulse directly on top of another with no cooling time) or overlap pulses

o Alternate between vertical and horizontal passes with each pass and move line positions on successive passes to ensure uniform coverage

o Movement should be controlled and Repetition Rate adjusted according to the patient’s tolerance

Treatment Steps: o Start treatment on the hallux (big toe) or thumb moving onto adjacent

toes/fingers o Use multiple passes until the recommended number of pulses has been delivered o Repeat either sequence until the recommended number of pulses have been

delivered Treat each toe/finger to point of discomfort, then move to the adjacent

toe/finger OR Treat hallux/thumb with 50-75 pulses at a time then move to smaller

toes/fingers with 25 pulses per digit at a time. o The number of passes may change from patient to patient depending on patient

tolerance o It should be noted that the pain tolerance lowers with each pass o Pause treatment for 5-10 seconds in between passes for patient comfort o White flashes or “sparks” can occur during treatment

It is recommended that all 10 toes/fingers be treated

Endpoint for treatment is number of pulses o Though the goal temperature is NOT the endpoint, it can help indicate if

enough heat is being delivered to the tissue.

Post Operative Care

To help prevent re-infection: o Wear clean shoes/socks home after treatment o Wash sheets, disinfect shower/bath and vacuum carpets day of treatment o Apply anti-fungal cream 2X per day for approximately 2 weeks to 3+ months

depending severity of the infection o Apply anti-fungal powder to all shoes at least 1x per week for at least 1+ month o Keep nails trimmed and cleaned (disinfecting instruments after each use) o Do not walk barefoot in public places (pool, gym, etc.)

Nail polish may be applied 24 hours after treatment Number of treatments will depend on severity of the Onychomycosis / Toenail Fungus

o The average time interval between treatments is 4-6 weeks Due to slow nail growth, results may not be noticeable for 3+ months

o Toenails may take 9-12+ months and fingernails may take 6-9+ months to grow out Severely infected nails may take longer If a blister develops, treat as a wound Cold gel packs or cool compresses may be applied post-treatment on hot spots

Matrix or Proximal nail fold

Incorrect Technique

Correct Technique

Distance Beam

Laser Beam (treatment area)

June 2013 D1018 Rev.G p. 6

TEMPORARY INCREASE OF CLEAR NAIL IN PATIENTS WITH ONYCHOMYCOSIS/ NAIL FUNGUS – PERFORMING THE PROCEDURE

1 mm Spot Size Podiatry Setting

Avoiding Complications Anesthetics or nerve blocks are not recommended as patient feedback is required Patients with neuropathy may not be able to provide feedback

o Increased risk of adverse events Do not treat over or close to tattoos Implants

o Reaction to metal implants is unknown o Pacemaker - stay at least 6 inches away from implant

Prepping the Patient Remove nail polish and clean toes/fingers Remove or cover any jewelry (including toe rings) Clean all nails thoroughly Shave the treatment area if there is excessive hair Topical anesthetic should not be used as patient feedback is required If nail is thicker than 2mm, the nail may be debrided

o Smoke evacuator & laser plume mask filtered to 0.1 microns are recommended when debriding Nail may be notched with a file to assess growth of clear nail Pre-treatment photographs should be taken prior to the initial treatment for future reference Safety eyewear must be worn by ALL people in the treatment room Recommend that laser operator follow Universal Precautions (gloves, masks, etc.) Smoke Evacuator and/or laser plume masks filtered to 0.1 microns are optional during laser treatment

Selecting Treatment Parameters

Number of treatments will depend on severity o Typically 1-5 treatments, 4-6 weeks apart

Treatment parameters are pre-programmed for this treatment and can not be adjusted o Parameters delivered using the 1 mm adapter are listed in the Operator Manual

June 2013 D1018 Rev.G p. 7

Positioning the Handpiece

For safety, turn GenesisPlus unit off when attaching or removing adapter o Insert the 1mm adapter into the laser aperture port, lining up the

alignment pin on the adapter with the notch in the handpiece o Rotate adapter clockwise until metal standoff is at bottom center

(6 o’clock position) The 1mm treatment screen will appear only after adapter is fully inserted

into the handpiece o The 1mm treatment screen cannot be accessed if adapter is not

plugged into handpiece and in the 6 o’clock position The handpiece can not be placed in the cradle while adapter is attached Remove 1mm adapter after treatment

o Clean both sapphire crystals of adapter with alcohol or optical-grade acetone

Adapter must be removed from handpiece prior to Skin or Warts treatment

Performing the Treatment

Gel is not used Anesthetics (topical or injectable) are not recommended as patient feedback is

required Ensure nails are cleaned prior to treatment Treat the entire nail bed, matrix and lateral folds, extending approximately 2mm

past the nail Hold the handpiece perpendicular to the nail’s surface

o Place the metal standoff directly onto the nail o The treatment area will be visible in the red aiming beam directly above

the standoff Treatment Steps:

o Each burse of 10 micro-pulses should be placed adjacent to each other Do not stack or overlap micro-pulse bursts

o Treat each digit with a total of 4 passes Alternate between vertical and horizontal rows with each pass

o Pain tolerance may lower with each pass Pause for 5-10 seconds in between passes for patient comfort

o White flashes or “sparks” can occur during treatment Ensure nail is clean

o Endpoint is total number of passes not pulse count It is recommended that all 10 toes/fingers be treated

Post Operative Care

To help prevent re-infection: o Wear clean shoes/socks home after treatment o Wash sheets, disinfect shower/bath and vacuum carpets day of treatment o Apply anti-fungal cream 2X per day for approximately 2 weeks to 3+ months

depending severity of the infection o Apply anti-fungal powder to all shoes at least 1x per week for at least 1+ month o Keep nails trimmed and cleaned (disinfecting instruments after each use) o Do not walk barefoot in public places (pool, gym, etc.)

Nail polish may be applied 24 hours after treatment Number of treatments will depend on severity of the Onychomycosis / Toenail Fungus

o The average time interval between treatments is 4-6 weeks Due to slow nail growth, results may not be noticeable for 3+ months

o Toenails may take 9-12+ months and fingernails may take 6-9+ months to grow out Severely infected nails may take longer If a blister develops, treat as a wound Cold gel packs or cool compresses may be applied post-treatment on hot spots

Matrix or Proximal nail fold

June 2013 D1018 Rev.G p. 8

WARTS – PERFORMING THE PROCEDURE

Avoiding Complications Deep tissue injury and prolonged wound healing may occur

o Diseases such as Diabetes may impede wound healing Do not treat over or close to tattoos or permanent make-up Possible hair loss may occur Implants

o Reaction to metal implants or fillers is unknown o Pacemaker - stay at least 6 inches away from implant

Prepping the Patient Clean treatment area Shave the treatment area if there is excessive hair Anesthetics may be used for patient comfort

o Local anesthesia (lidocaine without epinephrine) is optional Recommend that laser operator follow Universal Precautions (gloves, masks, etc.) A smoke evacuator is recommended

o Laser plume masks filtered to 0.1 microns optional Pre-treatment photographs should be taken prior to the initial treatment for future reference Safety eyewear must be worn by ALL people in the treatment room

o Check the wavelength and optical density (>=6.1 @ 1064nm) marked on all operator goggles Selecting Treatment Parameters

Start with low fluence and longer pulse duration and adjust to epidermal response The target chromophore for the wart is the vascular component Parameters need to be adjusted according to location, size and/or color of wart Pulse Duration – measures in milliseconds (ms),

o Smaller, lighter target = Shorter pulse duration Recommended when treating over bottom of foot or over calloused area More aggressive treatment

o Larger, darker target/skin = Longer pulse duration Recommended when treating over bony areas, near joints or cuticles Less aggressive treatment

o Fluence – measured in J/cm2 o Smaller, lighter target = Higher fluence

Recommended when treating over bottom of foot or over calloused area More aggressive treatment

o Larger, darker target/skin = Lower fluence Recommended when treating over bony areas, near joints or cuticles Less aggressive treatment

Size Skin Type Fluence Pulse Width

Repetition Rate

# Treatments

# of Pulses

Wart I-VI 160-190J/cm2 8 – 15 ms N/A 1+ 1+

Select the back button icon the upper left side of the Genesis screen to access Wart screen. Repetition Rate and Temperature will not be displayed.

June 2013 D1018 Rev.G p. 9

Performing the Treatment Handpiece should be 2 cm away from skin instead of the 4cm recommended for other indications

o Only the larger aiming beam will be visible o The smaller working distance beam and the temperature readout will not be activated

Warts may need to be debrided prior to treatment Gel is not used Wart may “spark” when treated Some warts may require more than one pulse

o Do NOT stack pulses (Stacking pulses is placing one pulse directly on top of another with no cooling time) o Pause for a few seconds between pulses o Cool with ice/frozen gel pack in between pulses

Individual Warts Treatment Steps Pulse over the wart Do not treat outside the wart border Cool treatment area in between pulses If wart is smaller than laser beam:

o Assess surrounding tissue before placing additional pulses to avoid over-treatment of normal tissue

If wart is larger than laser beam: o Use less aggressive parameters o May require multiple treatments (treat small sections over multiple visits) o Place pulses with approx. 10%-50% overlap

Lighter/Smaller Warts = more overlap Larger/Darker Warts = less overlap

Mosaic Wart Treatment Steps Usually require multiple treatments Use less aggressive parameters Do NOT treat entire area of mosaic wart in one session

o Only treat the darker/thicker area; usually near center of wart o Do NOT overlap pulses; pulses should be placed adjacent or spaced out o Cool treatment area in between pulses

At each subsequent visit, repeat treatment steps End Point Check for end point after first pulse Desired endpoint is a slight ashen color that should occur immediately after pulse

o Can be a subtle color change o If surrounding skin becomes white or edematous, it was probably over-

treated and should be treated as a wound If endpoint not reached:

o Increase fluence by 5J and shorten pulse duration by minimum until you reach end point

o Cool treatment area prior to next pulse o Repeat “Treatment Steps”

Immediate post cooling with cold gel pack, Zimmer, etc. may be used for patient comfort

Post Operative Care

Warts usually have a black or crusty appearance within 24 hours after treatment May apply ointment of choice and non-stick dressing for patient comfort If a blister develops, treat as a wound Treated tissue usually sloughs within 1-4 weeks Deep tissue injury and prolonged wound healing may occur More then 1 treatment may be necessary (4-6 weeks apart) Cold gel packs or cool compresses may be applied post-treatment on hot spots

June 2013 D1018 Rev.G p. 10

SCARS AND SKIN TREATMENTS – PERFORMING THE PROCEDURE

Avoiding Complications Topical anesthetics or local anesthetics should not be used as patient feedback is required Patients with neuropathy may not be able to provide feedback

o Increased risk of adverse events Check with surgeon before starting treatment on fresh scars Extreme caution should be used when treating near the eye

o Always treat outside the orbital rim of the eye aiming the beam away from the orbit o Patient eye protection is required to avoid ocular damage o The laser beam should ALWAYS be pointed away from the eye and only applied to

the skin outside of the orbital rim o Distance from the orbit can often be increased by pulling the skin away from the eye for treatment

Do not treat over or close to tattoos or permanent make-up Possible hair loss may occur The Nd:YAG may affect a tooth if exposed

o Moist gauze may be placed between the lips and teeth Implants

o Reaction to metal implants is unknown o Pacemaker - stay at least 6 inches away from implant o Reaction to fillers is unknown

Preparing the Patient Clean skin removing all make-up Shave the treatment area if there is excessive hair A white eyeliner pencil can be used to divide the treatment area into smaller grids if necessary Treatment of a test area should be performed and observed prior to the treatment Topical anesthetic should not be used as patient feedback is required Pre-treatment photographs should be taken prior to the initial treatment for future reference Recommend that laser operator follow Universal Precautions (gloves, masks, etc.) Safety eyewear must be worn by ALL people in the treatment room

o Check the wavelength and optical density (>=6.1 @ 1064nm) marked on all operator goggles

Selecting Treatment Parameters

Start with low fluence and slow repetition rate to observe laser-tissue interaction. Adjust to patient tolerance and epidermal response

Sensitive areas, darker skin types, highly vascular scars and areas of dense hair or recent sun exposure may require lower fluences or lower repetition rates

Size Skin Type Fluence Pulse Width

Repetition Rate

# Treatments

# of Pulses

Large Area (face, neck, or

chest)

I-IV 12-18 J/cm2 0.3 ms 7 – 10 Hz 4-6 8,000 – 12,000

V-VI 8-14 J/cm2 0.3 ms 5 – 8 Hz 4-6

Small Area (scars)

I-IV 12-16 J/cm2 0.3 ms 4 – 8 Hz 2-6 500 – 1,000 Depending on the

size of the scar V-VI 8-12 J/cm2 0.3 ms 4 – 8 Hz 2-6

June 2013 D1018 Rev.G p. 11

Treatment Technique Gel is not used Topical anesthetics should not be used as patient feedback is required Hold the handpiece approximately 3-4 cm from the skin’s surface

o Ensure the distance beam is centered in the aiming beam. o The handpiece should be continuously moved in a zig-zag motion with even

distribution of pulses o Movement should be controlled and speed adjusted according to the

patient’s tolerance o Treat each region to point of discomfort and erythema (example shown),

then move to adjacent regions using multiple passes Depending on the user setting, the laser emits a distinct water drop sound every 25,

100 and 500 pulses or every 100, 1,000 and 5,000 pulses o These sounds can help keep track of treatment progress without looking at the

screen Dark skin, scars or hot spots may need cooling or a short break during treatment Treating Scars

o Check with surgeon before starting treatment on fresh scars o Always include the tissue surrounding the scar observing for erythema of

the scar as endpoint Scar will absorb more energy than surrounding skin Do not rely on heat in surrounding skin as an endpoint Decreased sensation of scar increases risk of burn

o Treat in a zig-zag movement across the scar Do not treat linearly

o Pausing and/or cooling with an ice/frozen gel pack during treatment may be necessary

o Several treatments may be necessary Treating Skin To improve treatment uniformity and outcomes, divide the face into multiple regions

(example shown) o Forehead –divide in half o Periocular – Do NOT treat upper lids o Cheeks divide into 2-3 sections o Perioral areas

The vermillion border may be treated The Nd:YAG may harm a tooth if exposed

Moist gauze may be placed between lips and teeth Extreme caution should be used when treating near the eye

o Patient eye protection is required to avoid ocular damage o The laser beam should ALWAYS be pointed away from the eye and only

applied to the skin outside of the orbital rim o Distance from the orbit can often be increased by pulling the skin away from

the eye for treatment

Post Operative Care

No special post operative care is typically required Erythema is normal and expected and resolves with time Edema is a normal reaction The average time interval between treatments is 2 - 4 weeks If a blister develops, treat as a wound Cold gel packs or cool compresses may be applied post-treatment on hot spots

June 2013 D1018 Rev.G p. 12

Fitzpatrick Classification Questionnaire

SCORE 0 1 2 3 4

What is the natural color of your hair? Sandy red Blond Chestnut, dark

blond Dark brown Black

What is the eye color? Light blue, Gray, Green

Blue, Gray, Green Blue Dark Brown Brownish

Black

What is the color of sun unexposed skin areas? Reddish Very pale Pale with beige

tint Light brown Dark brown

How many freckles on unexposed skin areas? Many Several Few Incidental None

What happens when you are in the sun TOO long without

sunblock?

Painful redness, blistering, peeling

Blistering followed by

peeling

Burns, sometimes followed by

peeling Rarely burns Never had a

problem

How well do you turn brown?

Hardly or not at all Light color tan Reasonable tan Tan very

easily Turn dark

very quickly

Do you turn brown within one day of sun exposure? Never Seldom Sometimes Often Always

How does your face respond to the sun? Very sensitive Sensitive Normal Very

resistant Never had a

problem

When did you last expose

yourself to the sun or artificial sun treatments?

More than 3 months ago

2-3 month ago 1-2 months ago Less than 1

month ago Less than 2 weeks ago

Do you expose the area to be treated to the sun? Never Hardly ever Sometimes Often Always

TOTAL

00-07 points = Skin type I 08-16 points = Skin type II 17-25 points = Skin type III 25-30 points = Skin type IV 30-40 points = Skin type V & VI