Identifiers
- 510(k) Number
- K063640 FDA 510(k)
- FDA Product Code
- HJO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1850 FDA 510(k)
- Regulation Number
- 886.1850 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The KOWA SL-15 is a biomicroscope, slit-lamp device that is AC-powered. It is designed for ophthalmic examinations and procedures.
The device is supplied by Kowa Co., Ltd. and has FDA 510K authorization. It is classified as a Class II medical device and is intended for use in ophthalmic settings.
Frequently asked questions
What is the KOWA SL-15 used for?
The KOWA SL-15 is a biomicroscope and slit-lamp device designed for ophthalmic examinations and procedures. It is AC-powered and intended for use in ophthalmic settings to provide detailed views of the eye.
How is the KOWA SL-15 supplied?
The KOWA SL-15 is supplied by Kowa Co., Ltd. It is an AC-powered device that comes ready for use in ophthalmic settings, though specific accessories or components are not detailed in the available information.
What is the regulatory status of the KOWA SL-15?
The KOWA SL-15 has FDA 510K authorization with K number K063640. It is classified as a Class II medical device and was determined to be substantially equivalent to other devices in its class.
Is the KOWA SL-15 reusable or single-use?
The available information does not specify whether the KOWA SL-15 is designed for single-use or multiple uses. As a biomicroscope and slit-lamp device, it is typically designed for repeated use in clinical settings, but specific usage instructions would be provided by the manufacturer.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063640 | Class II | Active |
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Manufacturer
- Manufacturer
- Kowa Co. , Ltd.
Sources (1)
- FDA 510(k) K063640 24 fields · synced Sep 21, 2026