# K062963: Pharos Excimer Laser System, Model EX-308

- Pathway: 510(k) (Traditional)
- Applicant: Ra Medical Systems,Inc
- Decided: Apr 3, 2007 after 186 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K885026 (1989). 21 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993328: Surgilight, Inc Excimer Laser, Surgilight, Inc. (2000) Summary page 1.
- K020973: EX-308 Excimer Laser for Phototherapy Treatment of Vitiligo, Surgilight, Inc. (2002) Summary page 1.
- K992914: Excimer Laser Phototherapy System, AL7000, Acculase, Inc. (2000) Summary page 1.
- K003705: Xtrac Excimer Laser System, Model AL7000, Photo Medex, Inc. (2001) Summary page 1.
- K020847: Xtrac Excimer Laser System, Model AL7000, Photo Medex, Inc. (2002) Summary page 1.
- K011382: Xtrac Excimer Laser System, Model AL 7000, Photo Medex, Inc. (2001) Summary page 1.
- K041943: Xtrac XL, Model AL8000, Photo Medex, Inc. (2004) Summary page 1.
- K011197: Dermaclear UV-B Phototherapy System, Lumenis (2001) Summary page 1.
- K020591: Bclear, Lumenis (2002) Summary page 1.
- K021762: Bclear, Lumenis, Inc. (2002) Summary page 1.
- K024020: Theralight UV120-2 Uva/Uvb Phototherapy System, Theralight, Inc. (2003) Summary page 1.
- K022165: Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2, Theralight, Inc. (2002) Summary page 1.
- K041212: Houva 3 Phototherapy System, National Biological Corp. (2004) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Aug 23, 2019 · Class II · Z-1631-2020: At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiec
- Jun 30, 2014 · Class II · Z-2123-2014: RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed.

## Indications for use
The PHAROS Excimer Laser will be indicated for use for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.

Source page: https://510kreport.com/device/K062963
Methodology: https://510kreport.com/methodology