Sample Informed Consent Forms

Below is a sample Informed Consent Form for patients for training. Candela provides these forms for demonstration
only and does not accept any liability for their contents. It is essential that each clinic customize the Consent Forms
according to treatment procedure, local specific requirements and language.

Patient name________________________________________________________________________________________

Treatment sites______________________________________________________________________________________

I duly authorize _________________________________________________________________ to perform treatment.

I understand the procedure involves using either a picosecond 532/730/785/1064 nm laser designed for the
treatment of benign pigmented lesion and/or for variable degrees of fading or removal of tattoos. The Picoway
system’s Resolve 532 nm wavelength handpiece is cleared to treat wrinkles, Resolve 1064 nm wavelength handpiece
is cleared to treat wrinkles and acne scars, and the 532 nm Resolve Fusion handpiece is used to treat benign
pigmented lesions..

For benign pigmented lesion removal, I understand the procedure involves careful selection of wavelengths and pulse
durations to efficiently target and destroy the pigment while minimizing absorption by surrounding skin structures.
For the fading or removal of tattoos, I understand the procedure involves careful selection of wavelengths and pulse
durations to efficiently target and destroy the pigment while minimizing absorption by surrounding skin structures. For
the treatment of the appearance of acne scars or wrinkles, I understand the procedure involves partially resurfacing
the skin. I understand this device will not prevent me from developing or re-developing pigmented lesions and/
or acne scars or wrinkles and that I may not experience complete clearance of tattoos. Although this device is
effective in most cases, no guarantees can be made. Despite having multiple treatments, I understand that I may not
experience complete clearance, and that it may take multiple treatments. Some conditions may not respond at all,
and in rare cases, may become worse.

I understand that clinical results may vary depending on individual factors, including but not limited to medical history,
skin type, patient compliance with pre- and post-treatment instructions, and individual response to treatment.

ALTERNATIVE TREATMENTS - Alternative forms of treatment may not include the use of a picosecond laser but
may employ other light and laser based treatments. Skin care using topicals, chemical peels and surgery may be
substituted. In certain situations, the laser may offer a specific therapeutic advantage over other forms of treatment.
Alternatively, picoway laser treatments may not represent a better alternative to other forms of surgery of skin
treatment when indicated. Risks and potential complications are associated with alternative forms of treatment.

I am aware of the following possible experiences/risks:

PAIN & DISCOMFORT - The level of pain and discomfort varies with a person’s tolerance, and both may be
experienced during treatment.

REDNESS & SWELLING - Short term redness (erythema) or swelling (edema) of the treated area is common and
may occur. An urticarial (hive-like) reaction may occur as well.

PURPURA/BRUISING - Purpura (bruising) is a transient phenomenon that usually resolves with time.

HEMOSIDERIN STAINING - (Iron leaking into tissue from blood breakdown) may occur and usually resolves over
time, may require further treatment or may be permanent.

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SKIN SENSITIVITY - Itching, tenderness, or exaggerated responses to hot or cold temperatures may occur. This
typically resolves during the healing process, but, in rare situations, it may be chronic.

WOUND HEALING - Treatment can result in burning, blistering, or bleeding of the treated areas resulting in a wound.
If this occurs, please contact our office at _____________________________________________.

INFECTION - Infection is a possibility whenever the skin surface is disrupted, though proper wound care should
prevent this. If signs of an infection develop, such as pain, heat or surrounding redness, please contact our office at
__________________________________________________ . Herpes simplex virus infections (cold sores) around the
mouth can occur/ reoccur following a laser treatment. This applies to both individuals with a history of Herpes simplex
virus infections and individuals with no known history of Herpes simplex virus infections in the mouth area. If you had
cold sores in the past, please let your provider know as specific medications can be prescribed and taken both prior
to and following the procedure to suppress an infection from this virus.

BLEEDING - It is possible, though unusual, to experience bleeding or pinpoint bleeding during or after treatment.
Should any post-treatment pinpoint bleeding or bleeding occur, please contact our office immediately. Products
and medications such as aspirin, anti-inflammatories and blood thinners can increase the risk of bleeding. Non-
prescription herbal and dietary supplements can also increase the risk of bleeding. It is sometimes advised or
recommended that you avoid taking any blood thinners 7 to 14 days prior to and/or after your treatment. Speak to
your provider before stopping any medications.

PIGMENT CHANGES (Skin color) - There is a possibility that the treated area can become either hypopigmented
(lighter or white) or hyperpigmented (darker) in color compared to the surrounding skin. This is usually temporary but
can be permanent.

EPIDERMAL CRUSTING - Benign pigmented lesions may crust or scab as part of the healing process. It is
important not to pick or disturb the crusts as they heal. They may require medical attention if sensitivity or redness
occurs. Crusts will typically slough off 1-3 weeks after treatment.

SCARRING - Scarring is a rare occurrence, but it is a possibility whenever the skin surface is disrupted. To minimize
the chances of scarring, it is IMPORTANT that you follow all post-treatment instructions carefully.

TEXTURAL CHANGES/CUTANEOUS INDENTATIONS - Textural and/or skin changes may occur because
of treatment.

UNDESIRABLE HAIR REDUCTION - Hair reduction may occur at treatment sites. This is typically temporary but
can be permanent.

ALLERGIC REACTIONS - In some cases, local allergies to products used during or after treatment such as
adhesive, numbing agents, topical preparations and topical post-care have been reported. Systemic reactions, which
are more serious, may occur to drugs used during the procedure. Allergic reactions may require additional treatment.

EYE EXPOSURE - Eye injury is possible from laser procedures. Protective eyewear (shields or goggles) will be
provided to the patient and the providers. It is important to keep these on always during the treatment to protect your
eyes from injury.

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SUN EXPOSURE/ TANNING BEDS/ ARTIFICIAL TANNING - The use of these may increase risk of side effects
and adverse events. It has been advised that you discontinue and avoid UV exposure and artificial tanning before,
during, and after your treatment and recommended that you discontinue this practice all together as the effects of
the sun are damaging to the skin. A broad spectrum (UVA/UVB) sunscreen (SPF 30+) should be used when exposed
to the sun. Exposing the treated areas to sun may result in increased scarring, color changes, and poor healing.
Patients who tan, either outdoors or in a salon, should inform their treatment provider and either delay their treatment
or avoid UV exposure until your provider says it is safe to resume. The damaging effects of UV exposure occurs even
with the use of sunscreen or clothing coverage.

TREATMENTS - The number of treatments vary but multiple treatments may be required. The number of treatments
needed to clear your pigmented lesion and/or acne scarring is unknown.

LACK OF PERMANENT RESULTS - Treatment of pigmented lesions and/or facial rejuvenation may not completely
improve or prevent future skin disorders, lesions, or wrinkles. No technique can rcompletely reverse the signs of
aging. Additional PicoWay laser system procedures may be necessary to further improve the appearance of your
skin. You may be required to continue with a skin care maintenance program after a PicoWay procedure.

OTHER - You may be disappointed with the results of your PicoWay treatment. Infrequently, it is necessary to
perform additional PicoWay treatments or other approaches to improve your results.

UNKNOWN RISKS - There is the possibility that additional risk factors of PicoWay treatments may be discovered.

Additional Advisories

TRAVEL PLANS - Any treatment holds the risk of complications that may delay healing and delay your return to
normal life. Please let the treatment provider know of any travel plans, important commitments already scheduled or
planned, or time demands that are important to you, so that appropriate timing of your treatment can occur. There
are no guarantees that you will be able to resume all activities in the desired time frame.

SKIN CANCER/SKIN DISORDERS - PicoWay treatments and skin treatment procedures do not offer protection
against developing skin cancer or skin disorders in the future.

BODY PIERCINGS - Individuals who currently wear body-piercing jewelry in the treated region are advised that an
infection could develop from this activity.

MENTAL HEALTH DISORDERS AND ELECTIVE PROCEDURES - It is important that all patients seeking
to undergo elective treatments have realistic expectations that focus on improvement rather than perfection.
Complications or less than satisfactory results are sometimes unavoidable, may require additional treatments,
and can be stressful. Please openly discuss with your treatment provider, prior to the treatment, any history that
you may have of significant emotional distress or mental health disorders. Although many individuals may benefit
psychologically from the results of elective procedures, effects on mental health cannot be accurately predicted.

PATIENT COMPLIANCE - Follow all pre-and post-instructions carefully; this is essential for the success of your
outcome. Post-treatment instructions concerning appropriate restriction of activity, use of post-treatment care and
use of sun protection must be followed to avoid potential complications, increased pain, and unsatisfactory results.
Your treatment provider may recommend that you utilize a long-term skin care program to enhance healing and
results following a PicoWay treatment.

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Disclaimer

Informed consent documents are used to communicate information about the proposed treatment of a disease or
condition along with disclosure or risks and alternative forms of treatment(s). The informed consent process attempts
to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances.
However, informed consent documents should not be considered all-inclusive in defining other methods of care and
risks encountered. Your treatment provider may provide you with additional or different information, which is based on
all the facts in your particular case and the state of medical and device knowledge. Informed consent documents are
not intended to define or serve as the standard of care. Standards of care are determined based on all facts involved
in an individual case and are subject to change as scientific knowledge and technology advance and as practice
patterns evolve.

I certify that I have been fully informed of the nature and purpose of the procedure, expected outcomes and possible
complications, and I understand that no guarantee can be given as to the final result obtained. I am fully aware that my
condition is of cosmetic concern and that the decision to proceed is based solely on my expressed desire to do so.

I confirm that I have informed the staff regarding any current or past medical condition, disease or medication taken.

I consent to the taking of photographs and authorize their anonymous use for the purposes of medical audit,
education and promotion.

I certify that I have been given the opportunity to ask questions and that I have read and fully understand the contents
of this consent form.

Patient Name (Printed)_________________________________________________________________________________

Patient Signature_________________________________________________________________ Date ________________

Witness Name (Printed)________________________________________________________________________________

Witness Signature________________________________________________________________ Date ________________

© 2020 Candela Corporation. This material contains registered and unregistered trademarks, trade-names, service marks and brand names of Candela Corporation and its affiliates. All other
trademarks are the property of their respective owners. All rights reserved. DC94101, Rev B, January, 2020.