FDA.reportPublic FDA data

Silhouette Instalift

Primary DI
05060033040157
Brand
Silhouette Instalift
Company
Sinclair Pharma US Inc.
Model
SMS 30-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 16 cones. Both the monofilament and the cones are made from 82:18 L-lactide/ Glycolide bioresorbable (PURAC LG 8218) resin material.
Published
2015-09-24
Public version status
Update
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
05060033040164PackageGS15Not in Commercial Distribution
05060033041741PackageGS15In Commercial Distribution
05060033040157PrimaryGS10
05060033040270Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060033040164050600330401645060033040164
05060033041741050600330417415060033041741
05060033040157050600330401575060033040157
05060033040270050600330402705060033040270

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
9517347701quality@sinclairpharma.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
05060033043028Silhouette InstaliftSMS 31-PLG-3.0.1-NA2025-11-10
05060033040096Silhouette InstaliftSMS 28-PLG-3.0.1-NA2015-09-24
05060033040133Silhouette InstaliftSMS 29-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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Primary DI, Brand, Company table
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