# KOWA SL-15

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/kowa-sl-15-hjo>
- Manufacturer: [Kowa Co., Ltd.](https://devicerts.com/manufacturers/kowa-co-ltd) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: HJO

## Overview

*AI-generated summary, 2026-09-21. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K063640 · decision 2006-12-18 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K063640 [FDA 510(k)]
- FDA product code: HJO [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 886.1850 [FDA 510(k)]
- Advisory committee: Ophthalmic [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: KOWA SL-15, Kowa Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/kowa-sl-15-hjo (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/kowa-sl-15-hjo.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/kowa-sl-15-hjo
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.