# K233803: UltraClear Laser System (N/A)

- Pathway: 510(k) (Traditional)
- Applicant: Acclaro Corporation
- Decided: May 8, 2024 after 161 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: 20 generations back to K943450 (1995). 511 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 513 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173285: Joule System, Sciton, Inc (2018) Summary page 5.

## Most influential descendants
- K253245: Boston 2910 (Boston 2910) (2026), 0 descendants of its own

## Indications for use
The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia. Fractional Effects: The UltraClear Fractional Laser System with its accessories when used in Ultra mode is intended to produce fractional effects during skin resurfacing

Source page: https://510kreport.com/device/K233803
Methodology: https://510kreport.com/methodology