# K251981: Boston PICO (Boston PICO)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Aesthetics, Inc.
- Decided: Jan 30, 2026 after 217 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: 26 generations back to K943450 (1995). 287 ancestors in all.
No later device cites it as a predicate yet.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191685: PicoWay Laser System, Candela Corporation (2019) Summary page 5.

## Indications for use
The Boston PICO is indicated for surgical and cosmetic use in dermatology department, general surgery department and plastic surgery department, details are as follows: 1064 nm wavelength: – Remove tattoos of all skin types (Fitzpatrick skin type I-VI) in the following colors: black, brown, green, blue and purple. – Treat benign pigmented skin lesions of Fitzpatrick I-IV types. 532 nm wavelength: – Remove tattoos of Fitzpatrick skin type I-III in the following colors: red, yellow and orange. – Treat benign pigmented skin lesions of Fitzpatrick I-IV types. Microbeam handpieces (1064nm and 532nm) are used for the treatment of wrinkles for skin types I-IV.

Source page: https://510kreport.com/device/K251981
Methodology: https://510kreport.com/methodology