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510(k) Data Aggregation
K Number
K200140Device Name
Silhouette Instalift
Manufacturer
Silhouette Lift Inc.
Date Cleared
2020-03-27
(66 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
Silhouette Lift Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
Device Description
Silhouette Instalift Sutures are absorbable, sterile sutures. It is manufactured from a USP size 3-0 Poly/Glycolide/I-lactide suture material and an implantable grade of bioabsorbable PLGA resin (100% Poly (L-lactideco-glycolide) (co-monomer ratio: L-Lactide =82mol%: glycolide=18mol%). The 30 centimeter suture (+- 10 %) (SMS 28-PLG-3.0.1- NA), 27.5 centimeter suture (+- 10 %) (SMS 29-PLG-3.0.1-NA) or 26.8 centimeter suture (+- 10 %) (SMS 30-PLG-3.0.1-NA) are attached to two 12 centimeter straight stainless steel needles. All products are supplied sterile (EO) for single use only. Silhouette Instaliff Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.
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K Number
K191299Device Name
Silhouette Featherlift / Silhouette Lift
Manufacturer
Silhouette Lift Inc.
Date Cleared
2019-06-14
(31 days)
Product Code
GAW, GAM
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
Silhouette Lift Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silhouette Lift Sutures are for use in Midface suspension surgery to fixate the cheek sub dermis in an elevated position.
Device Description
Silhouette Lift Sutures are non-absorbable, sterile sutures.
SMS 01-PP-3.0.1-B-S, SMS 03-PP-3.0.1-CL and SMS 06-PP-3.0.1-B-L are made of 40.5 cm USP 3.0 size polypropylene suture with 6 cones made of a resorbable material (Lactide / Glycolyde 82:18) affixed to the suture. SMS 02-PP-2.0.1-B is a 37.3cm USP 2.0 size polypropylene suture with 10 cones made of resorbable material (Lactide / Glycolyde 82:18) affixed to the suture.
Attached to one end of each of the sutures is a straight needle and to the opposite end is a ½ circle taper needle.
All products are supplied sterile (EO) for single use only. Silhouette Lift Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.
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K Number
K171005Device Name
Silhouette Featherlift
Manufacturer
Silhouette Lift Inc.
Date Cleared
2017-05-03
(29 days)
Product Code
GAW, GAM
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
Silhouette Lift Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silhouette Lift Sutures are for use in Midface suspension surgery to fixate the cheek sub dermis in an elevated position.
Device Description
Silhouette Lift Sutures are non-absorbable, sterile sutures.
SMS 01-PP-3.0.1-B-S, SMS 03-PP-3.0.1-CL and SMS 06-PP-3.0.1-B-L are made of 40.5 cm USP 3.0 size polypropylene suture with 6 cones made of a resorbable material (Lactide / Glycolyde 82:18) affixed to the suture. SMS 02-PP-2.0.1-B is a 37.3cm USP 2.0 size polvpropvlene suture with 10 cones made of resorbable material (Lactide / Glycolyde 82:18) affixed to the suture.
Attached to one end of each of the sutures is a straight needle and to the opposite end is a ½ circle taper needle.
All products are supplied sterile (EO) for single use only. Silhouette Lift Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.
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