# Pharos EX-308

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/pharos-ex-308>
- Manufacturer: [Catheter Precision, Inc](https://devicerts.com/manufacturers/catheter-precision-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: GEX
- GMDN: Dermatological excimer laser system (47882)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00842362100017 · listed 2017-05-04 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K062963 · decision 2007-04-03 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1631-2020 · Class II · terminated · initiated 2019-08-23: 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.
- Z-2123-2014 · Class II · terminated · initiated 2014-06-30: 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.

## Identity

- Trade name: Pharos [FDA GUDID (AccessGUDID)]
- Generic name: Dermatological excimer laser system [FDA GUDID (AccessGUDID)]
- Model / reference: EX-308 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00842362100017 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K062963 [FDA GUDID (AccessGUDID)]
- FDA product code: GEX [FDA GUDID (AccessGUDID)]
- GMDN term: Dermatological excimer laser system (47882) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4810 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Pharos EX-308, Catheter Precision, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/pharos-ex-308 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/pharos-ex-308.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/pharos-ex-308
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.