# K971207: Softlight Q-Switched (ND:Yag) Laser

- Pathway: 510(k) (Traditional)
- Applicant: Thermolase Corp.
- Decided: May 13, 1998 after 412 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.
781 later devices descend from it; 4 cite it directly.
0 of 782 devices 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 System: named in the summary without a submission number

## Most influential descendants
- K022709: Medlite Q-Swithced Laser (2003), 742 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own
- K023967: Palomar Q-Yag ND:Yag Laser System (2003), 554 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own

## Indications for use
The SoftLight Q-switched Nd:YAG laser is indicated for use in combination with the supplied lotion for skin resurfacing. It is also indicated for the removal or lightening of unwanted facial or body hair.

Source page: https://510kreport.com/device/K971207
Methodology: https://510kreport.com/methodology