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Remington Tanfastic Countertop Facial Tanner

by Remington Products Company, LLC

510(k) K895409

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 NumberK895409 Date20 Oct 1989ClearedStatusActive

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  • Withdrawn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, 22 Sep 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, classified under medical specialty General and Plastic Surgery. It is a countertop facial tanner designed to provide ultraviolet exposure for tanning the face.

It was cleared through the FDA 510(k) process under K895409 with a substantially equivalent decision. The device is supplied as a non-sterile, reusable unit intended for use in professional or personal settings, with no indication of sterility, single-use status, or MRI safety provided in the data.

Other devices from Remington Products Company, LLC

Questions

AI-generated answers, 22 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 Remington Tanfastic Countertop Facial Tanner used for?

    This device is designed to provide ultraviolet exposure specifically for tanning the face, functioning as a countertop facial tanner classified under Booth, Sun Tan devices for general and plastic surgery applications.

  • Is the Remington Tanfastic Countertop Facial Tanner sterile or single-use?

    The device is supplied as a non-sterile, reusable unit, with no indication of sterility or single-use status in the authorization data, meaning it is intended for repeated use after appropriate cleaning between sessions.

  • How was the Remington Tanfastic Countertop Facial Tanner cleared for market?

    It received clearance through the FDA 510(k) process under submission K895409, with a substantially equivalent (SESE) decision issued on October 20, 1989, based on its classification as a Booth, Sun Tan device in general and plastic surgery.