DAAVLIN 3 Series
by Daavlin Distributing Co., the 23 variants
DAAVLIN 3 Series is a Class II device made by Daavlin Distributing Co., the, cleared under FDA 510(k) K050695 on 19 Apr 2005 and listed in FDA GUDID since 12 Dec 2024 (UDI-DI B2809861PH0048X5), 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 | NumberB2809861PH0048X5 | Date12 Dec 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050695 | Date19 Apr 2005 | StatusActive |
Official records
- FDA 510(k) database K050695
Across registries
- FDA 510(k) K050695 decided 19 Apr 2005 Active
- FDA GUDID UDI-DI B2809861PH0048X5 listed 12 Dec 2024 Listed
Timeline
- Cleared FDA 510(k) K050695
- Listed FDA GUDID B2809861PH0048X5
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Daavlin
- Generic name
- Ultraviolet phototherapy unit, professional
- Model / reference
- 3 Series
- Primary DI / UDI-DI
- B2809861PH0048X5
- 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
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