# K993328: Surgilight, Inc Excimer Laser

- Pathway: 510(k) (Traditional)
- Applicant: Surgilight, Inc.
- Decided: Jul 18, 2000 after 288 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: 1 generation back to K885029 (1989). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935525: Phototherapeutix Model 2480AB, Avex Industries, Ltd. (1995) Summary page 1.
- K885029: Houva II Uva/Uvb, National Biological Corp. (1989) Summary page 1.

## Most influential descendants
- K062963: Pharos Excimer Laser System, Model EX-308 (2007), 3 descendants of its own
- K172639: PALLAS 308/311 Solid-State UV Laser System (2017), 2 descendants of its own
- K191501: PALLAS 308/311 Solid-State UV Laser System (2020), 1 descendant of its own
- K223588: PALLAS Premium (2023), 0 descendants of its own

## Indications for use
The SurgiLight, Inc. EX-308 Excimer laser, handpieces and laser related accessories will be indicated for use for the treatment of psoriasis. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated devices. Surgilight, Inc. seeks no new indications for the EX-308 Excimer Laser.

Source page: https://510kreport.com/device/K993328
Methodology: https://510kreport.com/methodology