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Sign in to claim this brandWhat KEELER LIMITED makes
Keeler Limited manufactures ophthalmic diagnostic and surgical devices, including slit lamps, electronic cryosurgical systems, retinosopes (both line-powered and battery-operated), indirect and direct ophthalmoscopes, manual tonometers, and battery-powered skin transilluminators. Their portfolio also includes student training kits, disposable tonometers, and accessories like adapters and battery chargers for ophthalmic equipment.
The company’s devices are classified under FDA Class II, requiring pre-market notification (510(k)) and are listed under the FDA’s Unique Device Identifier (UDI) system. Keeler Limited is based in the United States.
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 Keeler Limited manufacture?
Keeler Limited specializes in ophthalmic diagnostic and surgical devices. Their product range includes slit lamps for eye examinations, electronic cryosurgical systems for precise tissue treatment, retinosopes (both line-powered and battery-operated) for assessing refractive errors, indirect and direct ophthalmoscopes for retinal examinations, manual tonometers for measuring intraocular pressure, and battery-powered skin transilluminators. They also produce student training kits, disposable tonometers, and accessories like adapters and battery chargers.
Where is Keeler Limited based?
Keeler Limited is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the FDA, which governs the classification and authorization of its devices.
How are Keeler Limited’s devices classified by the FDA?
Keeler Limited’s devices fall under FDA Class II, which is the second-highest risk category for medical devices. This classification requires pre-market notification via a 510(k) submission to demonstrate substantial equivalence to a predicate device. Class II devices are considered to have moderate risk and require special controls to ensure safety and effectiveness.
Which regulatory registries or databases list Keeler Limited’s devices?
Keeler Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) system, which standardizes identification for medical products. Additionally, their devices undergo 510(k) pre-market notifications, meaning they are documented in the FDA’s 510(k) database as part of the regulatory submission process. These registries help track compliance and authorization status.
Why do Keeler Limited’s ophthalmic devices require FDA classification?
The FDA classifies medical devices based on risk and intended use. Ophthalmic devices like slit lamps, tonometers, and cryosurgical systems are considered Class II because they pose moderate risks—such as potential eye damage or improper measurements—if not properly designed or used. This classification ensures that manufacturers like Keeler Limited must provide evidence of safety and performance through 510(k) submissions, which include clinical data, design controls, and manufacturing processes to mitigate risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 210164398
Catalogue (68)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SLZ 5XC Di TBL USA | 3020-P-2055 | FDA UDI | Class II | Active |
| SLZ 3XC DiR TBL USA | 3020-P-2049 | FDA UDI | Class II | Active |
| Finhoff Transilluminator 2.8v | 2903-P-1118 | FDA UDI | Class II | Active |
| Keeler Kapture Lite to Digital Upgrade | 3020-P-7042 | FDA UDI | Class II | Active |
| Cryomatic Console | 2509-P-1000 | FDA UDI | Class II | Active |
| 0.89mm Intra-Vitreal Pencil | 2509-P-8003 | FDA UDI | Class II | Active |
| SLZ 5XC DiR TBL USA | 3020-P-2058 | FDA UDI | Class II | Active |
| Slh 5xc 6v Ref | 3020-P-2003 | FDA UDI | Class II | Active |
| Slh 5xc 6v Tbl | 3020-P-2000 | FDA UDI | Class II | Active |
| Us Professional Complete Led Student Set | 1427-P-1127-500 | FDA UDI | Class II | Active |
| Lithium Double Charger | 1941-P-1368 | FDA UDI | Class II | Active |
| Rechargeable Handle & Refraction Stand Adaptor | 1911-P-1244-500 | FDA UDI | Class II | Active |
| Wireless Indirect Charger In Carton | 1941-P-1384 | FDA UDI | Class II | Active |
| SLH 5XC LED Di TBL USA | 3020-P-2015 | FDA UDI | Class II | Active |
| T-Type D-Kat, R-Type D-Kat | K133234 | FDA 510(k) | Class II | Active |
| Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box Of 100 | K152644 | FDA 510(k) | Class II | Active |
| Keeler Slit Lamp H-Series Digital (halogen Bulb Option), Keeler Slit Lamp H-Series Digital (led Option) | K140451 | FDA 510(k) | Class II | Active |
| Keeler Kapture Software | K140450 | FDA 510(k) | Class II | Active |
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