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Pharos EX-308

by Catheter Precision, Inc

Pharos EX-308 is a dermatological excimer laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Catheter Precision, Inc, cleared under FDA 510(k) K062963 on 3 Apr 2007 and listed in FDA GUDID since 4 May 2017 (UDI-DI 00842362100017), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K062963

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842362100017 UDI-DI Date4 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062963 Date3 Apr 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062963 decided 3 Apr 2007 Active
  • FDA GUDID UDI-DI 00842362100017 listed 4 May 2017 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1631-2020 FDA Class II initiated 23 Aug 2019

    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 handpiece switch is depressed. This malfunction can cause overtreatment, which could result in strong erythema, and possibly cause blisters.

    • Terminated Z-2123-2014 FDA Class II initiated 30 Jun 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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K062963
  2. Recall initiated FDA recalls Z-2123-2014
  3. Listed FDA GUDID 00842362100017
  4. Recall initiated FDA recalls Z-1631-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pharos
Generic name
Dermatological excimer laser system
Model / reference
EX-308
Primary DI / UDI-DI
00842362100017
510(k) Number
FDA product code
GEX
GMDN term
Dermatological excimer laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dermatological excimer laser system

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Catheter Precision, Inc

See all devices from Catheter Precision, Inc →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)