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Quasar C100, Baby Quasar Plus, Quasar Md Plus; Wrinkle Reduction Device

by Silverbay, LLC, D/B/A Quasar Bio-Tech

510(k) K130225

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK130225 Date11 Jul 2013ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2973-2018 FDA Class II initiated 29 Jun 2018
    • Terminated Z-2975-2018 FDA Class II initiated 29 Jun 2018
    • Terminated Z-2974-2018 FDA Class II initiated 29 Jun 2018

    Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.

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  • Withdrawn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