The following data is part of a premarket notification filed by Silhouette Lift Inc. with the FDA for Silhouette Instalift.
| Device ID | K200140 |
| 510k Number | K200140 |
| Device Name: | Silhouette Instalift |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Silhouette Lift Inc. 1 Technology Drive F211 Irvine, CA 92618 |
| Contact | Anthony Dibernardo |
| Correspondent | Anthony Dibernardo Silhouette Lift Inc. 1 Technology Drive F211 Irvine, CA 92618 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-03-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SILHOUETTE INSTALIFT 87019765 5950448 Live/Registered |
Sinclair Pharmaceuticals Limited 2016-04-29 |
![]() SILHOUETTE INSTALIFT 86373714 5166796 Live/Registered |
Sinclair Pharmaceuticals Limited 2014-08-21 |