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Sign in to claim this brandLabtician 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
- —
- —
- [email protected]
- Phone
- 905-829-0055
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 248911026
Catalogue (153)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Boucher DeGroot Head Positioning Glasses | 8080 | FDA UDI | Class I | Active |
| Silicone Strip | S 3013 | FDA UDI | Class II | Active |
| Labtician Lid Load™ 1.4 grams | SG14 | FDA UDI | Class II | Active |
| Silicone Lace™ 2mm | S 5020 | FDA UDI | Class II | Active |
| 2.5mm Grooved Strip | S 2992-M | FDA UDI | Class II | Active |
| Round Sponge 2mm | S 1982-2 | FDA UDI | Class II | Active |
| Round Sponge 7.5mm x 50mm | S 1982-7.5 | FDA UDI | Class II | Active |
| Oblong Sponge | S 1986-4 | FDA UDI | Class II | Active |
| Tantalum Weight 1.8 gram Pink | NST18PK | FDA UDI | Class II | Active |
| Double Tantalum Clip 2.0mm | S 566 | FDA UDI | Class II | Active |
| Silicone Strip | S 2965 | FDA UDI | Class II | Active |
| Oval Sponge | S 1981-5 | FDA UDI | Class II | Active |
| Tantalum Weight 2.8 gram | NST28 | FDA UDI | Class II | Active |
| Silicone Tire Wide Groove | S 2999 L | FDA UDI | Class II | Active |
| Round Sponge 2.5mm | S 1982-2.5 | FDA UDI | Class II | Active |
| Combo Pack | S 8719 | FDA UDI | Class II | Active |
| Combo Pack | S 2583 | FDA UDI | Class II | Active |
| Meridional Implant - Flat | S 2978 | FDA UDI | Class II | Active |
| Silicone Tire 10mm | S 3016 | FDA UDI | Class II | Active |
| Tantalum Set (2.0g to 2.8g) and 60 strips 5 weights | NST200 | FDA UDI | Class II | Active |
| Tantalum Weight 1.2 gram Pink | NST12PK | FDA UDI | Class II | Active |
| Pad | S 2993 | FDA UDI | Class II | Active |
| Grooved Part Thickness Sponge | S 1983-2.5 | FDA UDI | Class II | Active |
| 3.0mm Round Sponge | S 1982-3-M | FDA UDI | Class II | Active |
| Gonio Left | LGP2000-OS | FDA UDI | Class II | Unknown |
| Silicone Strip | S 2992 | FDA UDI | Class II | Active |
| LLL Proportional 1.0 grams | SGP10 | FDA UDI | Class II | Active |
| Labtician Oval Sleeve™ | S 3083 | FDA UDI | Class II | Active |
| Silicone Tire 6mm | S 3010 | FDA UDI | Class II | Active |
| Circling Band | S 2969 | FDA UDI | Class II | Active |
| Combo Pack | S 6983 | FDA UDI | Class II | Active |
| Partial Thickness Sponge | S 1984-2.5 | FDA UDI | Class II | Active |
| Tantalum Weight 2.2 gram | NST22 | FDA UDI | Class II | Active |
| Silicone Strip | S 4055 | FDA UDI | Class II | Active |
| Round Sponge 5mm | S 1982-5 | FDA UDI | Class II | Active |
| Tantalum Weight 2.0 gram Pink | NST20PK | FDA UDI | Class II | Active |
| Tantalum Weight 2.0 gram | NST20 | FDA UDI | Class II | Active |
| LLL Proportional 0.6 grams | SGP06 | FDA UDI | Class II | Active |
| Oval Sponge | S 1981-7.5 | FDA UDI | Class II | Active |
| Silicone Strip | S 2971 | FDA UDI | Class II | Active |
| Silicone Tire 6.0mm | S 2994 | FDA UDI | Class II | Active |
| Accessory Sponge | S 1987-8 | FDA UDI | Class II | Active |
| Silicone Strip | S 4065 | FDA UDI | Class II | Active |
| Silicone Sleeve | S 3019 | FDA UDI | Class II | Active |
| Grooved Sponge | S 1983-2.3 | FDA UDI | Class II | Active |
| Gonio Right | LGP1000-OD | FDA UDI | Class II | Unknown |
| Silicone Tire | S 3017 | FDA UDI | Class II | Active |
| Tantalum Weight 1.0 gram Pink | NST10PK | FDA UDI | Class II | Active |
| Labtician Lid Load™ 1.8 grams | SG18 | FDA UDI | Class II | Active |
| Labtician Lid Load Gold Eyelid Weight Implants | K983607 | FDA 510(k) | Class II | Active |
Related Companies
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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