The following data is part of a premarket notification filed by Silhouette Lift, Inc. with the FDA for Silhouette Instalift.
| Device ID | K142061 |
| 510k Number | K142061 |
| Device Name: | SILHOUETTE INSTALIFT |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SILHOUETTE LIFT, INC. 1 Technology Drive Suite F211 Irvine, CA 92618 |
| Contact | Juan Carlos Serna |
| Correspondent | Juan Carlos Serna 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 | 2014-07-30 |
| Decision Date | 2015-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060033040164 | K142061 | 000 |
| 05060033040140 | K142061 | 000 |
| 05060033040102 | K142061 | 000 |
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 |