NQE
9 FDA 510(k) clearances · Product code
267 daysmedian time to decision
525 days90th percentile
9clearances measured
FDA profile
- Official device name
- Microscope, Specular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- FDA definition
- Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Konan Specular Microscope XVII (K191558) | Konan Medical, Inc. | 2020-03-26 |
| Specular Microscope CEM-530 (K173980) | Nidek Co., Ltd. | 2018-03-14 |
| EM-4000 Specular Microscope (K171313) | Tomey Corporation | 2018-01-19 |
| Specular Microscope CEM- 530 (K151706) | Nidek Co., Ltd. | 2016-03-17 |
| SP-1PSpecular Microscope (K142417) | Topcon Corporation | 2015-05-29 |
| SPECULAR MICROSCOPE CEM-530 (K130565) | Nidek Co., Ltd. | 2013-11-27 |
| KONAN SPECULAR MICROSCOPE XIV (K120264) | Konan Medical, Inc. | 2012-04-11 |
| NONCON ROBO PACHY F&A (K062763) | Konan Medical, Inc. | 2008-02-22 |
| KERATO ANALYZER (EKA) (K040373) | Konan Medical, Inc. | 2004-03-19 |
Track NQE automatically
Every clearance here is in the API, with alerts when new ones post.