MR4 MR4 Laser System
MR4 MR4 Laser System (U600) is a Class II device made by Multi Radiance Medical, cleared under FDA 510(k) K080102 on 20 Aug 2008 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00852556007015), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00852556007015 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080102 | Date20 Aug 2008 | StatusActive |
Official records
- AccessGUDID record 00852556007015
- FDA 510(k) database K080102
Across registries
- FDA 510(k) K080102 decided 20 Aug 2008 Active
- FDA GUDID UDI-DI 00852556007015 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K080102
- Listed FDA GUDID 00852556007015
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MR4
- Generic name
- Musculoskeletal infrared phototherapy unit, non-wearable
- Model / Ref / Catalog
- MR4 Laser System, U600
- Primary DI / UDI-DI
- 00852556007015
- 510(k) Number
- FDA product code
- ILY
- GMDN term
- Musculoskeletal infrared phototherapy unit, non-wearable
- Device class
- Class II
- Regulation number
- 890.5500
- GUDID distribution status
- In Commercial Distribution
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