FDA.reportPublic FDA data

Silhouette Instalift

Primary DI
05060033043028
Brand
Silhouette Instalift
Company
Sinclair Pharma US Inc.
Model
SMS 31-PLG-3.0.1-NA
Device 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.
Published
2025-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142061000
K163676000
K200140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142061000SILHOUETTE INSTALIFTSilhouette Lift, Inc.2015-04-24GAM
K163676000Silhouette InstaLiftSilhouette Lift, Inc.2017-06-16GAM
K200140000Silhouette InstaliftSilhouette Lift, Inc.2020-03-27GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060033043035PackageGS15In Commercial Distribution
05060033043028PrimaryGS10
05060033045176Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060033043035050600330430355060033043035
05060033043028050600330430285060033043028
05060033045176050600330451765060033045176

GMDN Terms#

Term, Definition table
TermDefinition
Lift thread, bioabsorbableA sterile filament made of a bioabsorbable material [e.g., poly-L-lactide (PLLA), poly(lactic-co-glycolic acid) (PLGA)] with projections (e.g., barbs or cones) along its length intended to be surgically implanted typically during a cosmetic surgical procedure for alternative lifting (e.g., face, neck, breast). The device is inserted through dermis and tacked to deep fascia where the projections produce tension for elevation of the subdermis. It is available in a variety of lengths and may be supplied with dedicated disposable implantation tools (e.g., needle, cannula).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9517347701safety@sinclair.com

Regulatory Flags#

DUNS number
017003388
Device count
2
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060033040096Silhouette InstaliftSMS 28-PLG-3.0.1-NA2015-09-24
05060033040133Silhouette InstaliftSMS 29-PLG-3.0.1-NA2015-09-24
05060033040157Silhouette InstaliftSMS 30-PLG-3.0.1-NA2015-09-24
05060033040171Silhouette Lift SMS 01-PP-3.0.1-B-S2015-09-24
05060033040195Silhouette LiftSMS 02-PP-2.0.1-B2015-09-24
05060033040232Silhouette LiftSMS 06-PP-3.0.1-B-L2015-09-24
05060033040218Silhouette LiftSMS 03-PP-3.0.1-CL2015-09-24

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