DAAVLIN 3 Series

• FDA 510(k) K050695 decided 19 Apr 2005 Active
• FDA GUDID UDI-DI B2809861PH0048X6 listed 12 Dec 2024 Listed

1. 19 Apr 2005 Cleared FDA 510(k) K050695
2. 12 Dec 2024 Listed FDA GUDID B2809861PH0048X6

Trade name

Daavlin

Generic name

Ultraviolet phototherapy unit, professional

Model / reference

3 Series

Primary DI / UDI-DI

B2809861PH0048X6

510(k) Number

K050695 ↗

FDA product code

FTC

GMDN term

Ultraviolet phototherapy unit, professional

Device class

Class II

Regulation number

878.4630

GUDID distribution status

In Commercial Distribution

Category: Ultraviolet phototherapy unit, professional

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• DAAVLIN 1 Series Open recall

  Class II

  FDA 510(k) K220840 Active Cleared 22 Apr 2022 GUDID on market

• DAAVLIN 3 Series

  Class II

  FDA 510(k) K050695 Active Cleared 19 Apr 2005 GUDID on market

• DAAVLIN 4 Series Open recall

  Class II

  FDA 510(k) K220840 Active Cleared 22 Apr 2022 GUDID on market

• DAAVLIN Phothera 600

  Class II

  FDA 510(k) K073587 Active Cleared 18 Jan 2008 GUDID on market

See all devices from Daavlin Distributing Co., the →