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Labtician Ophthalmics, Inc

US

Last updated May 24, 2026

What Labtician Ophthalmics, Inc makes

Labtician Ophthalmics, Inc produces bioabsorbable scleral buckling devices, including silicone tires and sponges for retinal repair, as well as implantable eyelid weights in various weights and materials like tantalum. Their portfolio also includes reusable surgical procedure kits for general ophthalmic use, non-silicone skin adhesive tapes for dressing fixation, and magnifying prism readers for low-vision correction. Single-use ophthalmic tubing for irrigation, infusion, and aspiration is also part of their offerings.

The company’s devices are regulated under FDA classifications, including Class I, Class II, and Class III, with some authorised through 510(k) clearances, PMA submissions, and UDI listings. Products are manufactured and distributed from the United States, adhering to applicable FDA requirements for medical devices in those categories.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Labtician Ophthalmics, Inc specialize in producing?

Labtician Ophthalmics, Inc specializes in ophthalmic medical devices, including bioabsorbable scleral buckling devices like silicone tires and sponges used for retinal repair. They also produce implantable eyelid weights in materials such as tantalum, reusable general surgical procedure kits for ophthalmic use, non-silicone skin adhesive tapes for dressing fixation, magnifying prism readers for low-vision correction, and single-use tubing for ophthalmic irrigation, infusion, and aspiration.

Where is Labtician Ophthalmics, Inc based, and where are their devices manufactured?

Labtician Ophthalmics, Inc is based in the United States, where their devices are manufactured and distributed. The company adheres to applicable FDA requirements for medical devices, ensuring compliance with regulatory standards for the categories they produce.

Which regulatory registries or databases list Labtician Ophthalmics, Inc’s devices?

Labtician Ophthalmics, Inc’s devices are listed in the FDA’s 510(k) clearance registry, PMA (Premarket Approval) submissions, and UDI (Unique Device Identification) database. These registries reflect the regulatory pathways taken for their authorised products, including Class I, Class II, and Class III devices.

How are Labtician Ophthalmics, Inc’s devices classified under FDA regulations?

Labtician Ophthalmics, Inc’s devices fall under FDA classifications of Class I, Class II, and Class III. The classification depends on the risk associated with each product—for example, bioabsorbable scleral buckling devices and implantable weights may require higher scrutiny (Class II or III), while reusable surgical kits or non-silicone adhesive tapes may qualify as Class I or II. The specific pathway (e.g., 510(k), PMA) determines their regulatory status.

What types of ophthalmic procedures or conditions do Labtician Ophthalmics, Inc’s devices address?

Labtician Ophthalmics, Inc’s devices address a range of ophthalmic conditions and procedures. Their bioabsorbable scleral buckling devices (like silicone tires and sponges) are used in retinal detachment repair, while implantable eyelid weights help manage conditions like ptosis (drooping eyelid). Their reusable surgical kits support general ophthalmic procedures, and magnifying prism readers assist patients with low vision. Single-use tubing aids in intraocular surgeries requiring precise fluid management.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
labtician.com
LinkedIn
—
Facebook
—
Phone
905-829-0055
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
248911026

Catalogue (153)

Page 2 of 4
DeviceModel / ReferenceRegistriesClassStatus
Labtician Lid Load™ 2.6 grams SG26
FDA UDI
Class IIActive
Labtician Buckling Sleeve™ S 3093
FDA UDI
Class IIActive
Tantalum Weight 1.6 gram Pink NST16PK
FDA UDI
Class IIActive
Round Sponge 4mm S 1982-4
FDA UDI
Class IIActive
Silicone Strip S 4060
FDA UDI
Class IIActive
Labtician Lid Load™ 1.0 grams. SG10
FDA UDI
Class IIActive
Partial Thickness Sponge S 1984-3.3
FDA UDI
Class IIActive
Silicone Tire 7mm S 3014
FDA UDI
Class IIActive
5.0mm Round Sponge S 1982-5-M
FDA UDI
Class IIActive
Tantalum Weight 1.8 gram NST18
FDA UDI
Class IIActive
2.5mm Circling Band S 2987-M
FDA UDI
Class IIActive
Tantalum Weight 2.4 gram Pink NST24PK
FDA UDI
Class IIActive
Silicone Lace™ 2.5mm S 5025
FDA UDI
Class IIActive
Boat S 3012
FDA UDI
Class IIActive
Silicone Strip S 2970
FDA UDI
Class IIActive
Grooved Sponge S 1983-7.5
FDA UDI
Class IIActive
Oval Sponge S 1981-7
FDA UDI
Class IIActive
Tantalum Weight 0.8 gram Pink NST08PK
FDA UDI
Class IIActive
Tantalum Set (0.6g to 1.8g) and 60 strips 7 weights NST100
FDA UDI
Class IIActive
Silicone Strip S 4050
FDA UDI
Class IIActive
Wedge S 3022
FDA UDI
Class IIActive
Labtician Lid Load™ 2.0 grams SG20
FDA UDI
Class IIActive
Tantalum Weight 2.4 gram NST24
FDA UDI
Class IIActive
Labtician Lid Load™ 1.2 grams SG12
FDA UDI
Class IIActive
Double Tantalum Clip 2.5mm S 567
FDA UDI
Class IIActive
Circling Band S 2987
FDA UDI
Class IIActive
Oval Sponge S 1981-4
FDA UDI
Class IIActive
Grooved Sponge S 1983-3
FDA UDI
Class IIActive
LSO QuickSet LQ2000
FDA UDI
Class IActive
Oblong Sponge S 1986-3.5
FDA UDI
Class IIActive
Silicone Sleeve S 3071
FDA UDI
Class IIActive
Combo Pack S 8783
FDA UDI
Class IIActive
Round Sponge 1.5mm S 1982-1.5
FDA UDI
Class IIActive
Partial Thickness Sponge S 1984-3
FDA UDI
Class IIActive
Labtician Lid Load™ 2.2 grams SG22
FDA UDI
Class IIActive
Grooved Sponge S 1983-4
FDA UDI
Class IIActive
Grooved Sponge S 1983-3.5
FDA UDI
Class IIActive
Silicone Tire 10mm LG S 2996 L
FDA UDI
Class IIActive
Tantalum Weight 1.0 gram NST10
FDA UDI
Class IIActive
Tantalum Weight 2.6 gram NST26
FDA UDI
Class IIActive
Tantalum Weight 1.2 gram NST12
FDA UDI
Class IIActive
Tantalum Weight 1.4 gram Pink NST14PK
FDA UDI
Class IIActive
Grooved Sponge S 1983-3
FDA UDI
Class IIActive
Round Tunnel Sponge 5mm S 1982-5T
FDA UDI
Class IIActive
Silicone Strip S 2967
FDA UDI
Class IIActive
Meridional Implant S 2988
FDA UDI
Class IIActive
LLL Proportional 1.2 grams SGP12
FDA UDI
Class IIActive
Labtician Lid Load™ 2.4 grams SG24
FDA UDI
Class IIActive
Grooved Part Thickness Sponge S 1983-2.8
FDA UDI
Class IIActive
Circling Band S 2950
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

Not available yet.

Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Labtician Ophthalmics, Inc. OAKVILLE Ontario · CA FEI 3002807445