Versa Lite

FDA 510(k) K073503 · Diomedics, Inc.

Substantially Equivalent

510(k) numberK073503

Submission

Device name
Versa Lite
Applicant
Diomedics, Inc.
Laguna Niguel, CA, US
Received
December 13, 2007
Decision date
January 23, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Versa Lite cleared by the FDA?

Versa Lite (K073503) received a 510(k) decision of Substantially Equivalent on January 23, 2008, 41 days after the submission was received.

What is the product code of K073503?

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