# K993209: Softlight Q-Switched ND: Yag Laser with Optional Beam-Shrinking Handpiece Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Thermolase Corp.
- Decided: Dec 23, 1999 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ThermoLase SoftLight Q-Switched Nd:YAG Laser with optional SofTouch™ Scanner accessory: named in the summary without a submission number

## Indications for use
The ThermoLase SoftLight Q-Switched Nd:YAG Laser is indicated for use with the beam-shrinking handpiece for the removal or significant reduction in intensity of black and/or blue-black tattoos. The laser, without the beam-shrinking handpiece is also indicated for use in combination with the ThermoLase supplied topical lotion in removing or lightening unwanted facial or body hair and for laser skin resurfacing.

Source page: https://510kreport.com/device/K993209
Methodology: https://510kreport.com/methodology