SPECULAR MICROSCOPE CEM-530
FDA 510(k) clearance K130565 · decided 2013-11-27
Clearance details
- K-number
- K130565
- Device name
- SPECULAR MICROSCOPE CEM-530
- Applicant
- Nidek Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-04
- Decision date
- 2013-11-27
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- NQE
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Nidek EC-5000 Excimer Laser System (P970053/S017) | Nidek Co., Ltd. | 2018-01-12 |
| EC-5000 EXCIMER LASER SYSTEM (P970053/S016) | Nidek Co., Ltd. | 2017-06-08 |
| NIDEK EXCLAIMER LASER SYSTEM EC-5000 (P970053/S015) | Nidek Co., Ltd. | 2015-03-30 |
| NIDEK EXCIMER LASER SYSTEM EC-5000 (P970053/S013) | Nidek Co., Ltd. | 2014-11-21 |
| NIDEK EXCIMER LASER SYSTEM EC-5000 (P970053/S014) | Nidek Co., Ltd. | 2014-11-14 |
| NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM (P970053/S011) | Nidek Co., Ltd. | 2013-09-30 |
| NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S012) | Nidek Co., Ltd. | 2012-12-12 |
| NIDEK EC-5000 EXCIMER LASER (P970053/S010) | Nidek Co., Ltd. | 2006-11-08 |