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Silhouette Lift

FDA UDI

Class II (US FDA UDI)

by Sinclair Pharma US Inc.

Identity

Trade Name
Silhouette Lift FDA UDI
Generic Name
Lift thread, partially-bioabsorbable FDA UDI
Device Name
Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture along with a blunt needle. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position. FDA UDI
Model / Reference
SMS 06-PP-3.0.1-B-L FDA UDI
Description
Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture along with a blunt needle. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position. FDA UDI

Identifiers

Primary DI / UDI-DI
05060033040232 FDA UDI
510(k) Number
K060414 FDA UDI
K171005 FDA UDI
FDA Product Code
GAM FDA UDI
GAW FDA UDI
GMDN Term
Lift thread, partially-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 FDA UDI
878.5010 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Silhouette Lift by Sinclair Pharma US Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K060414 also covers:

K171005 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sinclair Pharma US Inc.

Sources (1)

  • FDA UDI e53acde7-14cb-45f0-98d5-d854083ab9eb 37 fields · synced May 30, 2026