# K020973: EX-308 Excimer Laser for Phototherapy Treatment of Vitiligo

- Pathway: 510(k) (Traditional)
- Applicant: Surgilight, Inc.
- Decided: Mar 29, 2002 after 3 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K001705: Statsign Electrode Conductivity Gel, Graham-Field Electrode Conductivity Gel, Models 004008, 48-4000 2GF, 48-4000GF, Chester Labs, Inc. (2000). Our OCR of the scanned summary read K001705, FDA’s number for Statsign Electrode Conductivity Gel, Graham-Field… (Chester Labs, Inc.), which shares no word with the summary’s name for the device, “PhotoMedix”, apart from generic ones like “system”. Kept off the family tree.

## 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 is indicated for use for the treatment of psoriasis and for the treatment of vitiligo.

Source page: https://510kreport.com/device/K020973
Methodology: https://510kreport.com/methodology