3 Series Phototherapy Cabinet

FDA 510(k) K063621 · Daavlin Co.

Substantially Equivalent

510(k) numberK063621

Submission

Device name
3 Series Phototherapy Cabinet
Applicant
Daavlin Co.
Bryan, OH, US
Received
December 5, 2006
Decision date
January 17, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FTC – Light, Ultraviolet, Dermatological
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4630
Specialty
General, Plastic Surgery

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Questions and answers

When was 3 Series Phototherapy Cabinet cleared by the FDA?

3 Series Phototherapy Cabinet (K063621) received a 510(k) decision of Substantially Equivalent on January 17, 2007, 43 days after the submission was received.

What is the product code of K063621?

The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.