Evaluation of the Efficacy and Safety of PiQo4 for Facial Skin Rejuvenation

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be entered into the study:

- Healthy Female/Male.

- Age= 18-70 (Adults).

- Fitzpatrick skin phototype = I-V

- Exhibiting at least two facial sub-areas with visible wrinkles with pigmentation
and/or acne scars.

- Able to read, understand and provide written Informed Consent.

- Able and willing to comply with the treatment/follow-up schedule and post treatment
care

- Willingness to provide a brief medical history including disclosure of any prescribed
or over-the-counter medications taken within the past 6 months.

- Willingness to allow Focus Medical (the study Sponsor) and Lumenis and the
investigators to use de-identified photographs of the treated area for presentation
and publication purposes.

- Daily use of sunscreen for the duration of the study

- Women of child-bearing potential are required to use a reliable method of birth
control (such as an intrauterine device, birth control pills, condom with spermicidal,
NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or
abstinence) during the course of the study.

Exclusion Criteria:

Any of the following will exclude the subject from the study:

- Pregnant, intending to become pregnant during the course of study, less than 3 months
postpartum or less than 3 months after completion of breastfeeding

- Prior skin laser, light or other energy device treatment in treated area within 6
months of initial treatment or during the course of the study.

- Known hypersensitivity or contraindications to anesthetic agents including lidocaine
and its derivatives, and Toradol.

- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in
the treated area, unless treatment is conducted following a prophylactic regimen.

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

- Having Melasma.

- Having multiple dysplastic Nevi in are to be treated.

- Having an excessive underlying vascular conditions (e.g. dense network of
capillaries).

- History of keloid scarring or of abnormal wound healing.

- Suffering from current or history of significant skin conditions in the treated area
or inflammatory skin conditions.

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

- Having a known anticoagulative or thromboembolic condition or taking anticoagulation
medications one week prior to and during the treatment course (to allow inclusion,
temporary cessation of use as per the subject's physician's discretion).

- Having a neurological disorder (including Multiple Sclerosis, Parkinson's disease).

- Having seizure disorder.

- Having fibromyalgia.

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

- Participation in a study of another device or drug within three months prior to
enrolment or during the study.

- Significant concurrent illness (e.g. uncontrolled diabetes) or any disease state that
in the opinion of the Investigator would interfere with the treatment or healing
process

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

- Subjects who are opposed to possible damage to the hair follicles with possible loss
of hair in the treatment area.

- Received the following treatments in the area of the face to be treated during or
within the noted timeframes prior to the study treatment:

1. Dermabrasion or chemical peel treatment within 3 months.

2. Any devices and/or Botox treatment within 6 months.

3. Collagen/fat injections or other methods of augmentation with injected or
implanted material in the treated area within 9 months.

4. Resurfacing procedure, face lift or eyelid surgery within a year.

5. Having a permanent implant in the facial skin area, such as an injected chemical
substance.

6. Any other surgery in treated area within 9 months of initial treatment or during
the course of the study

7. Use of retinoids, antioxidants or therapeutic skin nourishing supplements at
medicinal concentration within 2 months and oral retinoids within 6 months of the
study