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Martanique 6-TUBE Home Solarium

by Bainbridge Trading Co., Ltd.

510(k) K845001

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 NumberK845001 Date21 Feb 1985ClearedStatusActive

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  • Withdrawn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, 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 light, ultraviolet, dermatological device classified under product code FTC and regulation number 878.4630. It is substantially equivalent to a legally marketed device and received traditional 510(k) clearance from the FDA.

It is manufactured by Bainbridge Trading Co., Ltd. and was cleared on February 21, 1985, under K number K845001. The device is intended for general and plastic surgery applications as indicated by the advisory committee classification.

Other devices from Bainbridge Trading Co., Ltd.

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 MARTANIQUE 6-Tube Home Solarium used for?

    This device is a light, ultraviolet, dermatological device intended for general and plastic surgery applications, as indicated by its advisory committee classification and product code FTC under regulation 878.4630.

  • How was the MARTANIQUE 6-Tube Home Solarium approved for market?

    It received traditional 510(k) clearance from the FDA on February 21, 1985, under K number K845001, based on being substantially equivalent to a legally marketed device.

  • Who manufactures the MARTANIQUE 6-Tube Home Solarium and where is it located?

    The device is manufactured by Bainbridge Trading Co., Ltd., located at 210 Sound Beach Ave., Old Greenwich, CT 06870, United States.