Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the
PicoWayTM device-fractional handpiece 532nm and/or 1064nm according to the study protocol.
Subjects will be followed by phone 7 days post first treatment by study staff, and will
return for two follow‐up (FU) visits at the clinic at: 6 weeks and 12 weeks following the
last treatment.

Methodology described in the protocol to evaluate efficacy and safety of treatments will be
carried out at each visit at the clinic.

Inclusion Criteria:

1. Healthy female and male subjects between 18 to 75 years of age

2. Has Fitzpatrick skin type I-VI

3. Subjects seeking treatment for acne scars and wishes to undergo laser treatments for
improvement

4. Have bilateral moderate to severe facial acne scars

5. Willing to receive the proposed PicoWayTM fractional treatments and comply with all
study (protocol) requirements

6. Willing to have photographs and images taken of the treated areas to be used in
evaluations, publications and presentations (subject identity will be masked)

7. For female subjects: not pregnant or lactating and is either post-menopausal,
surgically sterilized, or using a medically acceptable form of birth control at least
3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant,
barrier methods with spermicide or abstinence)

8. Informed consent process is completed and subject consent is signed

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago,
and/or breast feeding

2. Hypersensitivity to light exposure

3. Active sun tan in facial area

4. Suffering from significant skin conditions in the treated areas or inflammatory skin
conditions, including, but not limited to, open lacerations or abrasions,
hidradenitis, or dermatitis of the treatment area prior to treatment (duration of
resolution as per the Investigator's discretion) or during the treatment course

5. Is taking medication(s) for which sunlight is a contraindication

6. Has a history of squamous cell carcinoma or melanoma

7. History of keloid scarring, abnormal wound healing and / or prone to bruising

8. History of epidermal or dermal disorders (particularly if involving collagen or
microvascularity), including collagen vascular disease or vasculitic disorders

9. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans
on using during the course of the study. Note: Skin must regain its normal degree of
moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and
skin surface roughness.

10. A laser procedure, a peel or has used lightening creams that was performed in the
area to be treated with the past six months

11. History of immunosuppression/immune deficiency disorders (including HIV infection or
AIDS) or currently using immunosuppressive medications

12. Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine

13. Subjects with pigmented lesions that are considered not acceptable by the study
investigator or any condition that, in the investigator's opinion, would make it
unsafe to treat.

14. As per the investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study