OPHTHALMOSCOPE F-10
FDA 510(k) clearance K072259 · decided 2008-05-06
Clearance details
- K-number
- K072259
- Device name
- OPHTHALMOSCOPE F-10
- Applicant
- Nidek Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-14
- Decision date
- 2008-05-06
- Days to decision
- 266 days
- Clearance type
- Abbreviated
- Product code
- MYC
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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| EIDON FA (K180526) | Centervue S.P.A. | 2018-07-16 |
| Retia 2 (K180293) | Centervue S.P.A. | 2018-05-30 |
| MAIA (K153181) | Centervue S.P.A. | 2016-06-08 |
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| P200DTx (K142897) | Optos Plc. | 2015-01-16 |
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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 |