Psoria-Light

FDA 510(k) K103540 · Psoria-Shield, Inc.

Substantially Equivalent

510(k) numberK103540

Submission

Device name
Psoria-Light
Applicant
Psoria-Shield, Inc.
Odessa, FL, US
Received
December 2, 2010
Decision date
February 10, 2011
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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More from Psoria-Shield, Inc.

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Questions and answers

When was Psoria-Light cleared by the FDA?

Psoria-Light (K103540) received a 510(k) decision of Substantially Equivalent on February 10, 2011, 70 days after the submission was received.

What is the product code of K103540?

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