NQE — Microscope, Specular Class II
Classification Details
- Product Code
- NQE
- Device Class
- Class II
- Regulation Number
- 886.1850
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191558 | konan medical | Konan Specular Microscope XVII | March 26, 2020 |
| K173980 | nidek co | Specular Microscope CEM-530 | March 14, 2018 |
| K171313 | tomey corporation | EM-4000 Specular Microscope | January 19, 2018 |
| K151706 | nidek co | Specular Microscope CEM- 530 | March 17, 2016 |
| K142417 | topcon corporation | SP-1PSpecular Microscope | May 29, 2015 |
| K130565 | nidek co | SPECULAR MICROSCOPE CEM-530 | November 27, 2013 |
| K120264 | konan medical | KONAN SPECULAR MICROSCOPE XIV | April 11, 2012 |
| K062763 | konan medical | NONCON ROBO PACHY F&A | February 22, 2008 |
| K040373 | konan medical | KERATO ANALYZER (EKA) | March 19, 2004 |