# Red Laser 2

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

- Canonical page: <https://devicerts.com/devices/red-laser-2>
- Manufacturer: [Thor Photomedicine Inc.](https://devicerts.com/manufacturers/thor-photomedicine-ltd) (United Kingdom)
- Device class: Class IIb (EU MDR); Class II (US FDA)
- FDA product code: ILY
- EMDN: Z12040202 PHOTOTHERAPY EQUIPMENT
- GMDN: Red-light phototherapy unit, professional (45688)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 506049413LX2SYSTEMJW · UDI-DI 05060494130695 · registered 2026-05-28 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 05060494130695 · listed 2026-05-07 · status: Listed (GUDID: in commercial distribution)
- **EUDAMED** · CE/MDR · European Union · 2026-MDR/QS-016 · issued 2026-02-20 · expires 2031-02-20 · status: Active
- **GUDID** · FDA 510(k) · United States · K033923 · decision 2004-03-17 · decision SESE · status: Active · from GUDID

## EU certificates

- 2026-MDR/QS-016 · Quality management system · MDR · notified body 3EC International a.s. · issued 2026-02-20 · expires 2031-02-20 · status: issued

## Recalls

No recall on record.

## Identity

- Trade name: Red Laser [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Red-light phototherapy unit, professional [FDA GUDID (AccessGUDID)]
- Device name: LX2.3 [EUDAMED]
- Model / reference: S2042 [EUDAMED]; 2 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 05060494130695 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 506049413LX2SYSTEMJW [EUDAMED]
- Direct marketing DI: 05060494130695 [EUDAMED]
- 510(k) Number: K033923 [FDA GUDID (AccessGUDID)]
- FDA product code: ILY [FDA GUDID (AccessGUDID)]
- EMDN code: Z12040202 [EUDAMED]
- GMDN term: Red-light phototherapy unit, professional (45688) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 890.5500 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: France [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Measuring function: Yes [EUDAMED]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: 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: Red Laser 2, Thor Photomedicine Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/red-laser-2 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/red-laser-2.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/red-laser-2
- 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.