KOWA SL-15
510(k) K063640
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063640 | Date18 Dec 2006 | StatusActive |
Official records
- FDA 510(k) database K063640
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HJO
- FDA applicant
- Kowa Co. , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 886.1850
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
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.
Devices cleared under K063640
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| KOWA SL-15 SL150K | SL150K | 04987646804031 | — | On the market |
Similar devices
Other devices filed under FDA product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered).
- SL 115 Classic by Carl Zeiss Meditec AG
- Slit Lamp SL-D301 by TOPCON CORPORATION
- Marco Ultra M3, Marco Ultra M4 by Takagi Seiko Co., Ltd.
- NEITZ SLIT LAMP SL-H1 by Neitz Instruments Co., Ltd.
- COHERENT FLOUROTRON MASTER by Lumenis
- KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) by KEELER LIMITED
- LUXVISION SLIT LAMP by Us Ophthalmic, LLC
- SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION by Carl Zeiss Meditec AG
- BURTON HAND HELD SLIT LAMP - MODEL SL750 by R.H. Burton Co.
- SLIT LAMP, Model: YF-100 by CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTD