FDA.reportPublic FDA data

Silhouette Lift

Primary DI
05060033040232
Brand
Silhouette Lift
Company
Sinclair Pharma US Inc.
Model
SMS 06-PP-3.0.1-B-L
Device 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.
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060414000
K171005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060414000KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTUREKmi Kolster Methods, Inc.2006-10-23GAW
K171005000Silhouette FeatherliftSilhouette Lift, Inc.2017-05-03GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060033040249PackageGS110Not in Commercial Distribution
05060033042007PackageGS110Not in Commercial Distribution
5060033040249PackageGS110Not in Commercial Distribution
05060033040232PrimaryGS10
05060033040317Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060033040249050600330402495060033040249
05060033042007050600330420075060033042007
05060033040232050600330402325060033040232
05060033040317050600330403175060033040317

GMDN Terms#

Term, Definition table
TermDefinition
Lift thread, partially-bioabsorbableA sterile filament made of a non-bioabsorbable material (e.g., polypropylene) with bioabsorbable projections (e.g., cones) attached 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 a needle(s).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius27 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
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
05060033040218Silhouette LiftSMS 03-PP-3.0.1-CL2015-09-24

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