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Sunbronze SB24C/65 Ultra

by Sunbronze

510(k) K896983

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 NumberK896983 Date3 Jan 1990ClearedStatusActive

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  • Withdrawn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, 25 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 product code LEJ and regulation number 878.4635. It is intended for use in general and plastic surgery settings as indicated by the advisory committee classification.

The device received FDA 510(k) clearance under number K896983 on January 3, 1990, following a traditional review process. It is classified as a Class II medical device and was determined to be substantially equivalent to a legally marketed device.

Other devices from Sunbronze

Questions

AI-generated answers, 25 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 SUNBRONZE SB24C/65 ULTRA intended for?

    The SUNBRONZE SB24C/65 ULTRA is intended for use in general and plastic surgery settings, as indicated by its advisory committee classification and product code LEJ under regulation 878.4635.

  • How was the SUNBRONZE SB24C/65 ULTRA cleared for market?

    The device received FDA 510(k) clearance under number K896983 on January 3, 1990, following a traditional review process and was determined to be substantially equivalent to a legally marketed device.

  • What regulatory classification does the SUNBRONZE SB24C/65 ULTRA have?

    The SUNBRONZE SB24C/65 ULTRA is classified as a Class II medical device, based on its FDA 510(k) clearance and product code LEJ under regulation 878.4635.