# K252369: Boston Pico755

- Pathway: 510(k) (Traditional)
- Applicant: Boston Aesthetics, Inc.
- Decided: Jan 21, 2026 after 175 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: 24 generations back to K943450 (1995). 278 ancestors in all.
No later device cites it as a predicate yet.
0 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210226: PicoSure Workstation, Cynosure, LLC (2021) Summary page 6.

## Indications for use
The Boston Pico755 is indicated for the removal of tattoos and benign pigmented lesions, including but not limited to Ota nevus, Hori spots (Hori nevus), and melasma. The Boston Pico755 with the 2 mm and 6 mm handpieces and the handpieces with Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

Source page: https://510kreport.com/device/K252369
Methodology: https://510kreport.com/methodology