FDA.reportPublic FDA data

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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNMNeedle, Ophthalmic Suturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800268430111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800268430111088002684301118800268430111

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
7042479103rnd@lynksolutec.com

Regulatory Flags#

DUNS number
695160136
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995295578V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320041V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320058V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320065V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320072V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320089V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320096V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320102V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320119V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320126V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320133V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320140V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320157V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320171V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320188V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320201V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320218V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320225V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320270V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320287V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320294V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320300V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
G346EEN008Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2026-04-20
G346EEN0132Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-12-17
04058935011574Osher Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011581Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011598Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011604Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011611Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011628McPherson Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10