# K202848: S2 Pigment Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Lightsense Technologies, Ltd.
- Decided: Dec 14, 2021 after 445 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: 22 generations back to K943450 (1995). 276 ancestors in all.
No later device cites it as a predicate yet.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160480: PicoSure Workstation, Cynosure, Inc. (2016) Summary page 4.

## Indications for use
S2 Pigment Removal System is intended for use in removal of tattoo ink. The S2 Pigment Removal System is indicated for the removal of tattoo ink according to the following wavelengths: 800 nm: The LightSense S2 800 nm Ti:Sapphire laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-III. 532 nm: The LightSense S2 532 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I - III. 1064 nm: The LightSense S2 1064 nm Nd-YAG laser system is indicated for tattoo removal for Fitzpatrick Skin Types I-VI.

Source page: https://510kreport.com/device/K202848
Methodology: https://510kreport.com/methodology