Kowa SL-17
FDA 510(k) K133755 · Kowa Co. , Ltd.
510(k) numberK133755
Submission
- Device name
- Kowa SL-17
- Applicant
- Kowa Co. , Ltd.
Chuo-Ku, Tokyo, JP - Received
- December 9, 2013
- Decision date
- March 11, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HJO – Biomicroscope, Slit-Lamp, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
Other 510(k)s with product code HJO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253834 | Visuref 600HJO · Traditional | Carl Zeiss Vision GmbH | 03/18/2026SE |
| K231760 | Hp-Oct (Hp-Oct)HJO · Traditional | Cylite Pty. , Ltd. | 03/08/2024SE |
| K222372 | Kowa SL-19HJO · Traditional | Kowa Company , Ltd. | 11/21/2022SE |
| K193188 | MiiS Horus Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 01/14/2020SE |
| K182306 | Sunkingdom Slit LampHJO · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 11/22/2018SE |
| K173771 | IOLMaster 700HJO · Traditional | Carl Zeiss Meditec, AG | 08/24/2018SE |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional | Chongqing Kanghua Ruiming S&T Co., Ltd. | 12/21/2017SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 10/06/2017SE |
| K162778 | Portable Slit Lamp MicroscopeHJO · Traditional | Suzhou Kangjie Medical, Inc. | 07/21/2017SE |
| K162684 | SL 220HJO · Traditional | Carl Zeiss Meditec, AG | 05/31/2017SE |
More from Carl Zeiss Meditec, AG
| 510(k) | Device | Decision |
|---|---|---|
| K222372 | Kowa SL-19HJO · Traditional | 11/21/2022SE |
| K191945 | KOWA nonmyd 8HKI · Traditional | 09/10/2019SE |
| K190573 | KOWA DR-1aHKI · Traditional | 06/04/2019SE |
| K112330 | Kowa VX-20HKI · Traditional | 02/16/2012SE |
| K101628 | Kowa Nonmyd WXHKI · Traditional | 01/26/2011SE |
| K091098 | Kowagenesis-DfHKI · Traditional | 08/07/2009SE |
| K091039 | Kowa, FM-600, Model LSS50MYC · Traditional | 08/07/2009SE |
| K091683 | Kowa VX-10 aHKI · Special | 07/02/2009SE |
| K083387 | Modification to Kowa Nonmyd Alpha-DiiiHKI · Special | 01/16/2009SE |
| K082767 | Kowa Nonmyd Alpha-DiiiHKI · Special | 10/21/2008SE |
Questions and answers
When was Kowa SL-17 cleared by the FDA?
Kowa SL-17 (K133755) received a 510(k) decision of Substantially Equivalent on March 11, 2014, 92 days after the submission was received.
What is the product code of K133755?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.