UVBioTek 80B
UVBioTek 80B is a Class II device made by Medtek Lighting Corp, cleared under FDA 510(k) K134009 on 15 Oct 2014 and listed in FDA GUDID since 9 Feb 2017 (UDI-DI B343B80), 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 | NumberB343B80 | Date9 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK134009 | Date15 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K134009
Across registries
- FDA 510(k) K134009 decided 15 Oct 2014 Active
- FDA GUDID UDI-DI B343B80 listed 9 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K134009
- Listed FDA GUDID B343B80
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- UVBioTek
- Generic name
- Ultraviolet phototherapy unit, professional
- Model / Ref / Catalog
- 80B
- Primary DI / UDI-DI
- B343B80
- 510(k) Number
- FDA product code
- FTC
- GMDN term
- Ultraviolet phototherapy unit, professional
- Device class
- Class II
- Regulation number
- 878.4630
- GUDID distribution status
- In Commercial Distribution
- Size
- Area/Surface Area — 1311 Square inchWeight — 170 Pound
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