Sun Tanning Bed

FDA 510(k) K853846 · Tan America Mfg.

Substantially Equivalent

510(k) numberK853846

Submission

Device name
Sun Tanning Bed
Applicant
Tan America Mfg.
Cedar Hill, TX, US
Received
September 16, 1985
Decision date
October 29, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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K862097Face TannerFTC · Traditional 06/17/1986SE
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Questions and answers

When was Sun Tanning Bed cleared by the FDA?

Sun Tanning Bed (K853846) received a 510(k) decision of Substantially Equivalent on October 29, 1985, 43 days after the submission was received.

What is the product code of K853846?

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