Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The PiXel8-Reveal contains two handpieces, each of which has its own indications for use. The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition, this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The PiXel8-Reveal contains two handpieces, each of which has its own indications for use. The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition, this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The PiXel8-Reveal system is a multi-function laser and radiofrequency system intended for dermatologic and general surgery purposes. The system is comprised of a single console with two handpieces: PiXel8-RF - a bipolar radiofrequency microneedling handpiece with disposable tips; Er:YAG - an Erbium:Yag single wavelength light-based handpiece. The system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source.
Summary parsed at:2026-06-01 05:26:48 UTC
