Solarc/SolRx E-Series E760M-UVBNB
Solarc/SolRx E-Series E760M-UVBNB is a Class II device made by Solarc Systems Inc, cleared under FDA 510(k) K103204 on 27 Apr 2011 and listed in FDA GUDID since 18 Sep 2023 (UDI-DI B219E760MUVBNB0), active as of 23 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 | NumberB219E760MUVBNB0 | Date18 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103204 | Date27 Apr 2011 | StatusActive |
Official records
- FDA 510(k) database K103204
Across registries
- FDA 510(k) K103204 decided 27 Apr 2011 Active
- FDA GUDID UDI-DI B219E760MUVBNB0 listed 18 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K103204
- Listed FDA GUDID B219E760MUVBNB0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Solarc/SolRx E-Series
- Generic name
- Ultraviolet phototherapy unit, home-use
- Model / reference
- E760M-UVBNB
- Primary DI / UDI-DI
- B219E760MUVBNB0
- 510(k) Number
- FDA product code
- FTC
- GMDN term
- Ultraviolet phototherapy unit, home-use
- Device class
- Class II
- Regulation number
- 878.4630
- GUDID distribution status
- In Commercial Distribution
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