# K253342: PICO-K

- Pathway: 510(k) (Traditional)
- Applicant: Speclipse, Inc.
- Decided: Dec 24, 2025 after 85 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: 27 generations back to K943450 (1995). 568 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 570 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202172: StarWalker, Fotona D.O.O. (2020) Summary page 6.
- K201773: Picohi, Hironic Co., Ltd. (2021) Summary page 6.

## Most influential descendants
- K261214: Pico Shining (Pico-K; Picofy) (2026), 0 descendants of its own

## Indications for use
The PICO-K is intended for use in the following indications at the specified wavelength: 1064 nm wavelength -Removal of tattoos for all skin types (Fitzpatrick 1-VI) to treat the following tattoo colors: black, brown, green, blue and purple -Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV -Treatment of acne scars in Fitzpatrick Skin Types Il-V -Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types 1-IV 532 nm wavelength -Tattoo removal in Skin Types I - III -Treatment of benign pigmented lesions in Fitzpatrick Skin Types 1-IV

Source page: https://510kreport.com/device/K253342
Methodology: https://510kreport.com/methodology