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Tan America Sun Up

by Tan America

510(k) K940753

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK940753 Date5 Apr 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LEJ
Device Class
Class II
Regulation
21 CFR Part 878.4635
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Booth, Sun Tan, as defined in the device name and openFDA data. It is a tanning booth designed for ultraviolet radiation exposure.

It is supplied by Tan America and was cleared through the FDA 510(k) process under K940753. The device is intended for general and plastic surgery settings, with no claims of sterility, single-use status, MRI safety, or specific sizes provided in the data.

Other devices from Tan America Mfg.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TAN AMERICA SUN UP used for?

    The TAN AMERICA SUN UP is a tanning booth designed for ultraviolet radiation exposure, intended for use in general and plastic surgery settings as indicated in its FDA 510(k) clearance.

  • How is the TAN AMERICA SUN UP supplied and is it sterile or single-use?

    The device is supplied by Tan America and is not described as sterile or single-use in the provided data; no claims of sterility, single-use status, or specific sizes are included in its FDA 510(k) submission.

  • What regulatory pathway was used for the TAN AMERICA SUN UP?

    The TAN AMERICA SUN UP was cleared through the FDA 510(k) process under submission number K940753, with a decision of substantially equivalent granted on April 5, 1994.