Search Results
Found 1 results
510(k) Data Aggregation
(134 days)
ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM
The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.
- Intense Pulsed Light Energy / wavelengths (530 950nm) .
The 530 - 950nm intense pulsed wavelengths are indicated for: The treatment of mild to moderate inflammatory Acne Vulgaris. The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins, facial veins and venous malformations.
Intense Pulsed Light Energy / wavelengths (610 - 950nm)
The 610 - 950nm intense pulsed wavelengths are indicated for: The removal of unwanted hair from all skin types and to effect stable longterm or permanent " hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
- Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Intense Pulsed Light Energy/wavelengths (415/630 - 950nm) 1 The treatment of mild to moderate inflammatory Acne Vulgaris.
Not Found
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer. It primarily discusses the regulatory approval of the Energist ULTRAPLUS™ VPL Intense Pulsed Light System and lists its indications for use.
This document does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in your prompt. Therefore, I cannot extract the requested information from this text.
Ask a specific question about this device
Page 1 of 1