FDA.report

LYNKS Frontalis Sling

Primary DI
08800268430111
Brand
LYNKS Frontalis Sling
Company
Lynk Solutec Inc.
Model
LSFS-2
Published
2026-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HNMNeedle, Ophthalmic Suturing

Product Code Classifications

CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800268430111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800268430111088002684301118800268430111

GMDN Terms

TermDefinition
Ptosis slingA sterile implantable device intended for the surgical correction of ptosis (dropping of the eyelid). It typically consists of a thread made of synthetic polymer (e.g., silicone), which may have attached needles, implanted into the upper eyelid and possibly lower forehead (frontalis muscle) to mechanically elevate the lid. Also referred to as a frontalis sling, it is left in situ where the position/retraction may be adjusted during use.

Sterilization Methods

Method

Contacts

PhoneEmail
7042479103rnd@lynksolutec.com

Regulatory Flags

DUNS number
695160136
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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