Evrl-Otc EVRL3-Otc
Evrl-Otc EVRL3-Otc is a Class II device made by Erchonia Corporation, cleared under FDA 510(k) K251843 on 12 Sep 2025 and listed in FDA GUDID since 9 Feb 2026 (UDI-DI 00858985006360), 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 | Number00858985006360 | Date9 Feb 2026 | StatusListed |
| United States | FDA 510(k) | NumberK251843 | Date12 Sep 2025 | StatusActive |
Official records
- AccessGUDID record 00858985006360
- FDA 510(k) database K251843
Across registries
- FDA 510(k) K251843 decided 12 Sep 2025 Active
- FDA GUDID UDI-DI 00858985006360 listed 9 Feb 2026 Listed
Timeline
- Cleared FDA 510(k) K251843
- Listed FDA GUDID 00858985006360
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Evrl-Otc
- Generic name
- Red/blue light phototherapy unit
- Model / reference
- EVRL3-OTC
- Primary DI / UDI-DI
- 00858985006360
- 510(k) Number
- FDA product code
- OLP
- GMDN term
- Red/blue light phototherapy unit
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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