# K233143: PiXel8-Reveal

- Pathway: 510(k) (Traditional)
- Applicant: Rohrer Aesthetics
- Decided: Feb 2, 2024 after 128 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 302 ancestors in all.
No later device cites it as a predicate yet.
0 of 303 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123777: Multilaser System, Ultralight Laser Technologies, LLC (2013) Summary page 5.
- K180654: PINXEL-RF system, Rohrer Aesthetics, LLC (2018) Summary page 5.

## 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 hemostatis. 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).

Source page: https://510kreport.com/device/K233143
Methodology: https://510kreport.com/methodology