Green Laser Photocoagulator GYC-500
FDA 510(k) clearance K152603 · decided 2016-05-02
Clearance details
- K-number
- K152603
- Device name
- Green Laser Photocoagulator GYC-500
- Applicant
- Nidek Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-11
- Decision date
- 2016-05-02
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Gamagori, JP
- Third-party review
- No
- Expedited review
- No
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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 |