FDA Product Code
FDA Product Code NQE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1850
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191558 | Konan Specular Microscope XVII | Konan Medical, Inc. | 2020-03-26 | Traditional | PDF ↗ |
| K173980 | Specular Microscope CEM-530 | Nidek Co., Ltd. | 2018-03-14 | Traditional | PDF ↗ |
| K171313 | EM-4000 Specular Microscope | Tomey Corporation | 2018-01-19 | Traditional | PDF ↗ |
| K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | 2016-03-17 | Traditional | PDF ↗ |
| K142417 | SP-1PSpecular Microscope | Topcon Corporation | 2015-05-29 | Traditional | PDF ↗ |
| K130565 | SPECULAR MICROSCOPE CEM-530 | Nidek Co., Ltd. | 2013-11-27 | Traditional | PDF ↗ |
| K120264 | KONAN SPECULAR MICROSCOPE XIV | Konan Medical, Inc. | 2012-04-11 | Special | PDF ↗ |
| K062763 | NONCON ROBO PACHY F&A | Konan Medical, Inc. | 2008-02-22 | Special | PDF ↗ |
| K040373 | KERATO ANALYZER (EKA) | Konan Medical, Inc. | 2004-03-19 | Traditional | PDF ↗ |
Product code NQE · Class II · Ophthalmic. Data: openFDA.