Skip to content

Remington Tanfastic Handheld Tanning Wand

by Remington Products Company, LLC

510(k) K895410

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895410 Date27 Nov 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
FTC
Device Class
Class II
Regulation
21 CFR Part 878.4630
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 light, ultraviolet, dermatological device classified under product code FTC and regulation number 878.4630. It is a handheld tanning wand designed for dermatological use involving ultraviolet light exposure.

It was cleared via the FDA 510(k) process under K895410 with a decision of substantially equivalent (SESE) on November 27, 1989. The device is supplied by Remington Products Company, LLC and is intended for use in general and plastic surgery settings as indicated by the advisory committee classification.

Other devices from Remington Products Company, LLC

Questions

AI-generated answers, 27 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 Handheld Tanning Wand used for?

    The Remington Tanfastic Handheld Tanning Wand is a light, ultraviolet, dermatological device designed for dermatological use involving ultraviolet light exposure, as indicated by its classification under product code FTC and regulation number 878.4630 for general and plastic surgery settings.

  • How was the Remington Tanfastic Handheld Tanning Wand cleared for market?

    The device was cleared via the FDA 510(k) process under submission K895410, receiving a substantially equivalent (SESE) decision on November 27, 1989, based on its traditional clearance pathway and advisory committee classification for general and plastic surgery.

  • Who manufactures the Remington Tanfastic Handheld Tanning Wand and where are they located?

    The Remington Tanfastic Handheld Tanning Wand is manufactured by Remington Products Company, LLC, located at 60 Main St., Bridgeport, CT 06604, United States, as specified in the device’s registration and address details.