Kowa Genesis-D Hand-Held Retinal Camera
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050271 FDA 510(k)
- FDA Product Code
- HKI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1120 FDA 510(k)
- Regulation Number
- 886.1120 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an ophthalmic, ac-powered camera designed for retinal imaging. It is a hand-held retinal camera used to capture images of the retina.
It is supplied as a reusable device and has received FDA 510(k) clearance under product code HKI and regulation number 886.1120. The device is intended for use in clinical settings where conventional table-mounted retinal cameras are not feasible, such as domiciliary situations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: KOWA Ophthalmic & Medical Equipment Genesis-D Handheld Retinal Camera ..., KOWA Ophthalmic & Medical Equipment Genesis-D Handheld Retinal Camera ..., Kowa Genesis-D hand held retinal camera - Medical Equip Shop, Genesis-D Brochure - Kowa Medical Care - PDF Catalogs | Technical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050271 | Class II | Active |
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Manufacturer
- Manufacturer
- Kowa Co. , Ltd.
Sources (1)
- FDA 510(k) K050271 24 fields · synced Sep 26, 2026