Kolster Methods, Inc., Featherlift Silhouette Suture

• • Terminated Z-2208-2015 FDA Class II ·initiated 2 Jul 2015 ·on shared 510(k) K060414

  Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K060414 ↗

FDA Product Code

GAW

Device Class

Class II

Regulation

21 CFR Part 878.5010

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Xub External Ultrasound

  Class II

  FDA 510(k) K010702 Active Cleared 9 Aug 2001

• STARS2000 Power Cannula

  Class II

  FDA 510(k) K012236 Active Cleared 19 Nov 2001

• Ssw-Sterile Solution Warmer

  Class I

  FDA 510(k) K002859 Active Cleared 16 Nov 2000

• Featherlift Extended Aptos Thread

  Class II

  FDA 510(k) K043591 Active Cleared 4 Mar 2005

• Irrigation or Infusion Pump K Pump

  Class II

  FDA 510(k) K991203 Active Cleared 15 Oct 1999