KONAN SPECULAR MICROSCOPE XIV
FDA 510(k) clearance K120264 · decided 2012-04-11
Clearance details
- K-number
- K120264
- Device name
- KONAN SPECULAR MICROSCOPE XIV
- Applicant
- Konan Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-30
- Decision date
- 2012-04-11
- Days to decision
- 72 days
- Clearance type
- Special
- Product code
- NQE
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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.