Home / 510(k) Clearances / K142061

510(k) K142061

SILHOUETTE INSTALIFT by Silhouette Lift, Inc. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2015
Date Received
July 30, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

Other clearances by Silhouette Lift, Inc.

  • K200140 — Silhouette Instalift (March 27, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K163676 — Silhouette InstaLift (June 16, 2017)
  • K171005 — Silhouette Featherlift (May 3, 2017)

Other clearances for product code GAM

  • K253852 — MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthet (February 6, 2026)
  • K252743 — STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MO (December 22, 2025)
  • K253620 — TroClose 1200 (December 16, 2025)
  • K252820 — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glyc (October 3, 2025)
  • K233265 — Monotime and Optime R (October 11, 2024)
  • K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (July 12, 2024)
  • K221527 — StitchKit (February 14, 2023)
  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
  • K212810 — MONOFIX PGCL, knotless wound closure device (August 5, 2022)
  • K211792 — StitchKit (July 16, 2021)