# K210847: UltraClear Fractional Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Fa International, LP
- Decided: Dec 10, 2021 after 263 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). 516 ancestors in all.
No later device cites it as a predicate yet.
0 of 517 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180508: Joule System, Sciton, Inc (2018) Summary page 4.

## Indications for use
The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use: General skin resurfacing procedures Ultra mode is further indicated for the following fractional applications: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

Source page: https://510kreport.com/device/K210847
Methodology: https://510kreport.com/methodology