Search Results

• The POLYLASE LP PULSED DUAL OUTPUT LASER is intended to effect 1. TEMPORARY HAIR REDUCTION in skin types I-IV with 755 nm output wavelength) and skin types IV-VI with 1064 nm output wavelength.
• 2. The POLYLASE LP PULSED DUAL OUTPUT LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-III with use of 755 nm wavelength and skin types IV and V with use of 1064 nm wavelength through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
• 3. FOR PHOTOCOAGULATION AND HEMOSTASIS OF DERMATOLOGICAL VASCULAR LESIONS with 1064 nm output wavelength.
• 4. FOR INCISION/EXCISION OF SOFT BODY TISSUES IN DERMATOLOGY with 1064 nm output wavelength.
• 5. FOR NONABLATIVE WRINKLE REDUCTION AND SKIN COLLAGEN REJUVENATION with 1064 nm output wayelongth

Not Found

This document is a 510(k) premarket notification approval letter for the Polylase™ LP Dual Output Alexandrite and Nd: Y AG Laser. It does not contain information about acceptance criteria or a study proving device performance in the format requested. The document primarily serves as an FDA clearance for the device to be marketed, based on its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information as it is not present in the provided text.

Ask a specific question about this device