Silhouette InstaLift

Suture, Absorbable, Synthetic, Polyglycolic Acid

SILHOUETTE LIFT, INC.

The following data is part of a premarket notification filed by Silhouette Lift, Inc. with the FDA for Silhouette Instalift.

Pre-market Notification Details

• Device ID: K163676
• 510k Number: K163676
• Device Name: Silhouette InstaLift
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: SILHOUETTE LIFT, INC. 1 TECHNOLOGY DRIVE SUITE F211 Irvine, CA 92618
• Contact: Doug Abel
• Correspondent: Brian Young; HEALTH POLICY ASSOCIATES, INC 690 CANTON STREET SUITE 302 Westwood, MA 02090
• Product Code: GAM
• CFR Regulation Number: 878.4493 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-27
• Decision Date: 2017-06-16
• Summary: summary