Eligibility Details:
Inclusion Criteria:
1. Subject is a healthy Male or Female at least 18 years of age
2. Subject has a vascular (blood vessels) and skin disorders or erythematous scars or
erythematous striae or wishes to improve skin laxity or skin firmness. In special
cases non-erythematous scars or non-erythematous striae may be allowed as well.
3. Fitzpatrick Skin Type I - VI
4. Subject must be able to read, understand and sign the Informed Consent Form
5. Subject must be willing and able to adhere to the treatment and follow-up schedule and
post-treatment care instructions
6. Subject must be willing to have limited sun exposure for the duration of the study,
including the follow-up period
7. Subject is willing to have photographs and/or videos taken of the treated area which
will be used, de-identified, in evaluations and may be used, de-identified, in
presentations and/or publications
8. For female candidates - subject must be post-menopausal, or surgically sterilized, or
using a medically acceptable form of birth control during the entire course of the
study.
Exclusion Criteria:
1. Subject is pregnant or planning to become pregnant during the study duration.
Pregnancy will be assessed by question at screening.
2. Subject has an active electrical implant anywhere in the body, such as a pacemaker or
an internal defibrillator.
3. Subject has an implant in the treated area (such as metal plates or screws) or an
injected chemical substance, including Botox and collagen injections (if the face area
is treated).
4. Subject has a known collagen (connective tissue) disorder, vascular disease,
scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).
5. Subject has a history of diseases stimulated by heat or sun exposure, such as
recurrent Herpes Simplex in the treated area, unless treatment is conducted following
a prophylactic regimen.
6. Subject has a history of immunosuppression/immune deficiency disorders (including HIV
infection or AIDS) or currently using immunosuppressive medications.
7. Having or undergoing any form of treatment for active cancer, or having a history of
skin cancer or any other cancer in the areas to be treated, including actinic
keratosis, presence of malignant or pre-malignant pigmented lesions.
8. Subject is suffering from significant concurrent illness, such as such as cardiac
disorders, diabetes (type I or II), or pertinent neurological disorders.
9. Subject has an infection or is suffering from current or has a history of significant
skin conditions in the treated area or inflammatory skin conditions, including, but
not limited to: photodermatoses, active acne, excessive skin dryness, psoriasis,
eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open
lacerations or abrasions and active cold sores or herpes sores prior to treatment
(duration of resolution as per the Investigator's discretion) or during the treatment
course.
10. 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 discretion).
11. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing
agents) one week before and after each treatment session.
12. Subject has a history of pigmentary disorders, particularly tendency for hyper- or
hypo-pigmentation.
13. Subject has a history of keloid scarring or of abnormal wound healing.
14. Subject has a known photosensitivity to the study laser wavelength, history of
ingesting medications known to induce photosensitivity, or history of seizure
disorders due to light.
15. Subject has undergone any surgical, light-based therapy or RF procedures in the
treatment area within 3 months of treatment or during the study.
16. Having undergone any other surgery in the treated area within 3 months of treatment
(or more if skin has not healed completely) or during the study.
17. Subject has undergone a facial dermabrasion or chemical peel treatment within 3 months
of treatment or during the study (if face is treated).
18. Having received Botox/collagen/fat injections or other methods of augmentation with
injected or implanted material in the treated area within 9 months of treatment or
during the study (if face is treated).
19. Subject has undergone a resurfacing procedure, face lift or eyelid surgery within a
year of treatment or during the study (if face is treated).
20. Subject has a tattoo or permanent make-up in the treated area.
21. Subject has systemically used retinoids, antioxidants or medical grade of skin
nourishing supplements within 2 months of treatment or during the study.
22. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning
during the study.
23. Participation in a study of another device or drug within three months prior to
enrollment or during the study.
24. As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
