EM-4000 Specular Microscope
FDA 510(k) K171313 · Tomey Corporation
510(k) numberK171313
Submission
- Device name
- EM-4000 Specular Microscope
- Applicant
- Tomey Corporation
Nagoya, JP - Received
- May 4, 2017
- Decision date
- January 19, 2018
- 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 |
| K151706 | Specular Microscope CEM- 530NQE · Traditional | Nidek Co., Ltd. | 03/17/2016SE |
| 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 |
|---|---|---|
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000)MXK · Traditional | 12/18/2025SE |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2)OBO · Traditional | 07/18/2025SE |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2OBO · Traditional | 04/27/2022SE |
| K073087 | Non-Contact Tonometer, Model FT-1000HKX · Traditional | 11/18/2008SE |
| K012803 | AL-2000 Combined Biometer and PachymeterIYO · Traditional | 04/08/2002SE |
Questions and answers
When was EM-4000 Specular Microscope cleared by the FDA?
EM-4000 Specular Microscope (K171313) received a 510(k) decision of Substantially Equivalent on January 19, 2018, 260 days after the submission was received.
What is the product code of K171313?
The FDA product code is NQE – Microscope, Specular, a Class II (moderate risk) device regulated under 21 CFR 886.1850.