Study of a Novel Laser for Skin Rejuvenation

A single-center prospective, open-label uncontrolled exploratory study to evaluate the safety
and efficacy of an investigational version of the enlighten™ 670nm laser for
photo-rejuvenation.

Subjects will receive up to 7 laser treatments, spaced 1 to 8 weeks apart, and will be
followed at 2 weeks (±1 week) post-first treatment and 12 weeks (±2 weeks) post-final
treatment. In addition, after each treatment, subjects will complete a 3 day post treatment
phone follow-up. At the Investigator's discretion, optional follow-up visits may also be
conducted at 6 weeks post-final treatment (±2 weeks).

Inclusion Criteria:

- Female or Male, 20 to 75 years of age (inclusive).

- Fitzpatrick Skin Type I - VI.

- Desires photo-rejuvenation of the skin or improvement in the appearance of acne
scarring.

- Subject has visible signs of acne scarring or moderate sun-damaged and/or aging skin
in the treatment area with visible areas acne lesions and scars, fine rhytides,
lentigines or pigmentation, diffused redness erythema and skin texture

- Subject must be able to read, understand and sign the Informed Consent Form.

- Must be willing and able to adhere to the treatment and follow-up schedule and
post-treatment care instructions.

- Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or
higher on the treatment area every day for the duration of the study, including the
follow-up period.

- Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes.

- Agree to not undergo any other procedure(s), including injectable agents, for skin
rejuvenation during the study and has no intention of having such procedures performed
during the course of the study.

- Post-menopausal or surgically sterilized, or using a medically acceptable form of
birth control at least 3 months prior to enrollment and during the entire course of
the study, and no plans to become pregnant.

Exclusion Criteria:

- Participation in a clinical trial of another drug, or device administered to the
target area, during the study.

- Any type of prior cosmetic treatment to the target area within 6 months of study
participation, such as laser or light-based procedures or surgery.

- Prior injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal
filler within 6 months of study participation.

- History of malignant tumors in the target area.

- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.

- Pregnant and/or breastfeeding.

- Having an infection, dermatitis or a rash in the treatment area.

- Significant concurrent illness, such as diabetes mellitus or cardiovascular disease,
e.g., uncontrolled hypertension.

- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.

- History of immunosuppression/immune deficiency disorders or currently using
immunosuppressive medications per investigator's discretion.

- History of vitiligo, eczema, or psoriasis.

- History of connective tissue disease, such as systemic lupus erythematosus or
scleroderma.

- History of seizure disorders due to light.

- Any use of medication that is known to increase sensitivity to light according to
Investigator's discretion.

- History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes
zoster (shingles) in the treatment area, unless treatment is conducted following a
prophylactic regimen

- History of pigmentary disorders, particularly tendency for hyper- or
hypo-pigmentation.

- Systemic use of retinoid, such as isotretinoin, as applicable, within 6 months of
study participation.

- Topical use of retinoid, such as isotretinoin, as applicable, on the treatment area
within 1 month of participation.

- Anytime in life, having have used gold therapy (gold salts) for disorders such as
rheumatologic disease or lupus.

- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning
during the study.

- Current smoker or history of smoking within 6 months of study participation. As per
the Investigator's discretion, any physical or mental condition which might make it
unsafe for the subject to participate in this study.