Zara Soft Tip Chin Implant

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K910458 ↗

FDA Product Code

FWP

Device Class

Class II

Regulation

21 CFR Part 878.3550

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Elastic Adhesive Bandage

  Class I

  FDA 510(k) K910436 Active Cleared 19 Mar 1991

• Psi-Tec Aspirator

  Class II

  FDA 510(k) K980392 Active Cleared 5 Mar 1998

• Psi-Tec Liposuction Aspirator

  Class II

  FDA 510(k) K981215 Active Cleared 1 Jul 1998

• Disposable Bag Decanter

  Class II

  FDA 510(k) K934179 Active Cleared 23 May 1994

• Zara Zone Iv Malar Implant Modification

  Class II

  FDA 510(k) K934233 Active Cleared 3 Feb 1994

• Byron Bivalve Nasal Splints

  Class II

  FDA 510(k) K863430 Active Cleared 17 Sep 1986

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