Microscope, Specular
The specular microscope is an ophthalmic device used to perform microscopic imaging and assessment of the corneal endothelial cell layer, either in vivo or in vitro, to evaluate cell density, morphology, and health as an aid in diagnosing corneal disease and monitoring corneal transplant outcomes. It is classified as FDA Class 2 under regulation 886.1850 in the Ophthalmic specialty, requiring 510(k) clearance. Product code NQE is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NQE
- Device Class
- FDA class 2
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191558 | Konan Specular Microscope XVII | Mar 26, 2020 | Substantially Equivalent | Konan Medical, Inc. |
| K173980 | Specular Microscope CEM-530 | Mar 14, 2018 | Substantially Equivalent | Nidek Co., Ltd. |
| K171313 | EM-4000 Specular Microscope | Jan 19, 2018 | Substantially Equivalent | Tomey Corporation |
| K151706 | Specular Microscope CEM- 530 | Mar 17, 2016 | Substantially Equivalent | Nidek Co., Ltd. |
| K142417 | SP-1PSpecular Microscope | May 29, 2015 | Substantially Equivalent | Topcon Corporation |
| K130565 | SPECULAR MICROSCOPE CEM-530 | Nov 27, 2013 | Substantially Equivalent | Nidek Co., Ltd. |
| K120264 | KONAN SPECULAR MICROSCOPE XIV | Apr 11, 2012 | Substantially Equivalent | Konan Medical, Inc. |
| K062763 | NONCON ROBO PACHY F&A | Feb 22, 2008 | Substantially Equivalent | Konan Medical, Inc. |
| K040373 | KERATO ANALYZER (EKA) | Mar 19, 2004 | Substantially Equivalent | Konan Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.