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Ultra Renew Plus

by Accord Media

510(k) K132833

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 NumberK132833 Date17 Jun 2014ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0822-2018 FDA Class II initiated 4 Dec 2017
    • Terminated Z-0820-2018 FDA Class II initiated 4 Dec 2017
    • Terminated Z-0821-2018 FDA Class II initiated 4 Dec 2017
    • Terminated Z-0819-2018 FDA Class II initiated 4 Dec 2017

    Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation

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  • Withdrawn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
OLP
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent