Manufacturer
Rohrer AestheticsPiXel8-Reveal
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K233143
- Device name
- PiXel8-Reveal
- Company
- Rohrer Aesthetics
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-09-27
- Decision date
- 2024-02-02
- Submission type
- Traditional
- Technology type
- Er:YAG(AI inferred)
- Clinical applications
- Skin resurfacingSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
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).
Intended Use
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).
Device Description
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