Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2

FDA 510(k) K022165 · Theralight, Inc.

Substantially Equivalent

510(k) numberK022165

Submission

Device name
Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2
Applicant
Theralight, Inc.
Carlsbad, CA, US
Received
July 3, 2002
Decision date
July 18, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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 Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 cleared by the FDA?

Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 (K022165) received a 510(k) decision of Substantially Equivalent on July 18, 2002, 15 days after the submission was received.

What is the product code of K022165?

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