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Brownie Booth BB1

by Weingart, Inc.

510(k) K842975

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 NumberK842975 Date17 Aug 1984ClearedStatusActive

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  • Withdrawn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, 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 Brownie Booth BB1 is a Class II medical device classified as a light, ultraviolet, dermatological instrument. It provides ultraviolet illumination intended for dermatological procedures and skin treatments.

The device received traditional 510(k) clearance (K842975) on August 17, 1984 and is listed under product code FTC. It is supplied by Weingart, Inc. in the United States and is regulated as a Class II device under regulation number 878.4630.

Other devices from Weingart, Inc.