Aart Malar Implant

• • Ongoing Z-0947-2026 FDA Class II ·initiated 26 Sep 2025

  Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances.

510(k) Number

K021419 ↗

FDA Product Code

LZK

Device Class

Class II

Regulation

21 CFR Part 878.3550

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Aart Silicone Sheeting

  Class II

  FDA 510(k) K022223 Active Cleared 8 Aug 2002

• Aart Silicone Tubing

  Class I

  FDA 510(k) K022306 Active Cleared 10 Oct 2002

• Aart Calf Implant Open recall

  Class II

  FDA 510(k) K022511 Active Cleared 26 Aug 2002

• Aart Nasal Implant

  Class II

  FDA 510(k) K021418 Active Cleared 2 Jul 2002

• Dimisil Scar Gel

  Class I

  FDA 510(k) K023678 Active Cleared 23 Jan 2003

• Aart Chin Implant Open recall

  Class II

  FDA 510(k) K021417 Active Cleared 2 Jul 2002

See all devices from Aesthetic and Reconstructive Technologies, Inc. →