Slit Lamp SL-D701
FDA 510(k) K133667 · Topcon Corp.
510(k) numberK133667
Submission
- Device name
- Slit Lamp SL-D701
- Applicant
- Topcon Corp.
North Reading, MA, US - Received
- November 29, 2013
- Decision date
- August 26, 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
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| 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 |
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| K232828 | IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional | 03/01/2024SE |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)OBO · Traditional | 10/30/2023SE |
| K221111 | Non-Mydriatic Retinal Camera NW500HKI · Traditional | 08/29/2022SE |
| K173119 | DRI OCT TritonOBO · Traditional | 01/19/2018SE |
| K171370 | IMAGEnet 6 Ophthalmic Data SystemNFJ · Traditional | 11/01/2017SE |
| K170164 | 3D OCT-1 MaestroOBO · Special | 03/03/2017SE |
| K161972 | Slit Lamp SL-D301HJO · Traditional | 12/09/2016SE |
Questions and answers
When was Slit Lamp SL-D701 cleared by the FDA?
Slit Lamp SL-D701 (K133667) received a 510(k) decision of Substantially Equivalent on August 26, 2014, 270 days after the submission was received.
What is the product code of K133667?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.