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Silhouette Instalift

FDA UDI

Class II (US FDA UDI)

by Sinclair Pharma US Inc.

Identity

Trade Name
Silhouette Instalift FDA UDI
Generic Name
Lift thread, bioabsorbable FDA UDI
Device Name
The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a single monofilament that holds two sets of 12 cones. Both the monofilament and the cones are made from 82:18 L-lactide/ Glycolide bioresorbable (PURAC LG 8218) resin material. FDA UDI
Model / Reference
SMS 29-PLG-3.0.1-NA FDA UDI
Description
The Silhouette Instalift device consists of two 304 Stainless Steel Surgical needles and an absorbable implant. The absorbable implant consists of a single monofilament that holds two sets of 12 cones. Both the monofilament and the cones are made from 82:18 L-lactide/ Glycolide bioresorbable (PURAC LG 8218) resin material. FDA UDI

Identifiers

Primary DI / UDI-DI
05060033040133 FDA UDI
510(k) Number
K142061 FDA UDI
K163676 FDA UDI
K200140 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Lift thread, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 FDA UDI
Commercial Distribution
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
MRI Safety
MR Safe FDA UDI

Category: Lift thread, bioabsorbable

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

Similar devices

Also classified as Lift thread, bioabsorbable.

Cleared under the same submission

K142061 also covers:

K163676 also covers:

K200140 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 649900d8-c3f4-4335-80f1-811ae27f74aa 36 fields · synced May 30, 2026