# K253245: Boston 2910 (Boston 2910)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Aesthetics, Inc.
- Decided: May 21, 2026 after 234 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). 517 ancestors in all.
No later device cites it as a predicate yet.
0 of 518 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233803: UltraClear Laser System (N/A), Acclaro Corporation (2024) Summary page 5.
- K180508: Joule System, Sciton, Inc (2018) Summary page 6.

## Indications for use
The Boston 2910 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.

Source page: https://510kreport.com/device/K253245
Methodology: https://510kreport.com/methodology