Specular Microscope CEM- 530
FDA 510(k) K151706 · Nidek Co., Ltd.
510(k) numberK151706
Submission
- Device name
- Specular Microscope CEM- 530
- Applicant
- Nidek Co., Ltd.
Gamagori, JP - Received
- June 24, 2015
- Decision date
- March 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQE – Microscope, Specular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Other 510(k)s with product code NQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191558 | Konan Specular Microscope XVIINQE · Traditional | Konan Medical, Inc. | 03/26/2020SE |
| K173980 | Specular Microscope CEM-530NQE · Traditional | Nidek Co., Ltd. | 03/14/2018SE |
| K171313 | EM-4000 Specular MicroscopeNQE · Traditional | Tomey Corporation | 01/19/2018SE |
| K142417 | SP-1PSpecular MicroscopeNQE · Traditional | Topcon Corporation | 05/29/2015SE |
| K130565 | Specular Microscope CEM-530NQE · Traditional | Nidek Co., Ltd. | 11/27/2013SE |
| K120264 | Konan Specular Microscope XivNQE · Special | Konan Medical, Inc. | 04/11/2012SE |
| K062763 | Noncon Robo Pachy F&ANQE · Special | Konan Medical, Inc. | 02/22/2008SE |
| K040373 | Kerato Analyzer (Eka)NQE · Traditional | Konan Medical, Inc. | 03/19/2004SE |
More from Konan Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…OBO · Traditional | 03/30/2023SE |
| K203130 | Ophthalmic Yag Laser System YC-200HQF · Traditional | 12/07/2020SE |
| K192045 | Ophthalmic Yag Laser System YC-200HQF · Traditional | 11/15/2019SE |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type SHKI · Traditional | 04/01/2019SE |
| K181345 | Image Filing Software NAVIS-EXNFJ · Traditional | 07/19/2018SE |
| K173980 | Specular Microscope CEM-530NQE · Traditional | 03/14/2018SE |
| K170302 | Yellow Laser Photocoagulator YLC-500HQF · Traditional | 06/23/2017SE |
| K163564 | Slit Lamp SL-2000HJO · Traditional | 05/19/2017SE |
| K152729 | Microperimeter MP-3HKI · Traditional | 06/06/2016SE |
| K152603 | Green Laser Photocoagulator GYC-500HQF · Traditional | 05/02/2016SE |
Questions and answers
When was Specular Microscope CEM- 530 cleared by the FDA?
Specular Microscope CEM- 530 (K151706) received a 510(k) decision of Substantially Equivalent on March 17, 2016, 267 days after the submission was received.
What is the product code of K151706?
The FDA product code is NQE – Microscope, Specular, a Class II (moderate risk) device regulated under 21 CFR 886.1850.