SL 220
FDA 510(k) K162684 · Carl Zeiss Meditec, AG
510(k) numberK162684
Submission
- Device name
- SL 220
- Applicant
- Carl Zeiss Meditec, AG
Jena, DE - Received
- September 26, 2016
- Decision date
- May 31, 2017
- 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
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| 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 |
| K163564 | Slit Lamp SL-2000HJO · Traditional | Nidek Co., Ltd. | 05/19/2017SE |
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| K233933 | CIRRUS HD-OCT Model 6000OBO · Traditional | 05/17/2024SE |
| K233421 | Rescan 700OBO · Traditional | 03/08/2024SE |
| K232944 | CALLISTO eyeNFJ · Special | 12/21/2023SE |
| K232051 | VISULAS greenHQF · Traditional | 10/24/2023SE |
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Questions and answers
When was SL 220 cleared by the FDA?
SL 220 (K162684) received a 510(k) decision of Substantially Equivalent on May 31, 2017, 247 days after the submission was received.
What is the product code of K162684?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.