Versaclear Skin Therapy System, Model 100

FDA 510(k) K061295 · Theralight, Inc.

Substantially Equivalent

510(k) numberK061295

Submission

Device name
Versaclear Skin Therapy System, Model 100
Applicant
Theralight, Inc.
Carlsbad, CA, US
Received
May 9, 2006
Decision date
May 25, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 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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More from Psoria-Shield, Inc.

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Questions and answers

When was Versaclear Skin Therapy System, Model 100 cleared by the FDA?

Versaclear Skin Therapy System, Model 100 (K061295) received a 510(k) decision of Substantially Equivalent on May 25, 2006, 16 days after the submission was received.

What is the product code of K061295?

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