510(k) K191299

Silhouette Featherlift / Silhouette Lift by Silhouette Lift, Inc. — Product Code GAW

K191299 is an FDA 510(k) premarket notification submitted by Silhouette Lift, Inc. for the device "Silhouette Featherlift / Silhouette Lift". The FDA issued a decision of Substantially Equivalent on June 14, 2019. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Silhouette Lift, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2019
Date Received
May 14, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type