Pivotal Study to Evaluate the Effectiveness of a Micro-coring Device Treating Moderate to Severe Facial Wrinkles

Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects
will be monitored for a period of 90 days after treatments.

Evaluation results will be based in the following:

- Wrinkle severity score assessed using the Lemperle Wrinkle Scale

- Subject Satisfaction Scale

- PI Global Aesthetic Improvement Scale

Inclusion Criteria:

- Males and females 40-70 years of age

- Fitzpatrick Skin Type I to IV as judged by the Investigator.

- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as
judged by the Investigator

- Able to provide written informed consent, understand and willing to comply with all
study related procedures and follow-up visits

Exclusion Criteria:

- Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma,
vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be
treated

- History of keloid formation or hypertrophic scarring

- History of trauma or surgery to the treatment areas in the past 6 months

- Scar present in the areas to be treated

- Silicone injections in the areas to be treated

- Injection of dermal fillers, fat or botulinum toxin, as well as any minimally
invasive/invasive medical device for skin treatment, in the study treatment areas,
within the past 6 months (i.e., dermabrasion, laser, RF devices)

- Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment

- Active, chronic, or recurrent infection

- History of compromised immune system or currently being treated with immunosuppressive
agents

- History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics
(e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or
epinephrine

- Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior
to treatment

- Treatment with aspirin or other blood thinning agents within 14 days prior to
treatment

- History or presence of any clinically significant bleeding disorder

- Any issue that, at the discretion of the Investigator, would interfere with assessment
of safety or efficacy or compromise the subject's ability to participate in the study

- Treatment with an investigational device or agent within 30 days before treatment or
during the study period

- Female and pregnant or plan on becoming pregnant during the study