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Ultra Tan Purple Pro

by Ultra Tan Intl. AB

510(k) K875190

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 NumberK875190 Date14 Jan 1988ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

The Ultra Tan Purple Pro is a sun tan booth designed for use in general and plastic surgery settings. It functions as a tanning device to provide ultraviolet light exposure.

This device is regulated under FDA 510(k) clearance number K875190. It is classified as a class 2 medical device under regulation number 878.4635.

Other devices from Ultra Tan Intl. AB

Questions

AI-generated answers, 21 Sep 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 intended use of the Ultra Tan Purple Pro?

    The Ultra Tan Purple Pro is a sun tan booth specifically designed to provide ultraviolet light exposure within general and plastic surgery settings.

  • How is this device regulated?

    The Ultra Tan Purple Pro is classified as a class 2 medical device under regulation number 878.4635 and holds FDA 510(k) clearance number K875190.

  • Which medical specialty is this device associated with?

    This device is categorized under the general and plastic surgery advisory committee, reflecting its intended application within those specific clinical environments.