Nidek EC-5000 Excimer Laser System
FDA premarket approval P970053/S017 · decided 2018-01-12
Approval details
- PMA number
- P970053
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nidek EC-5000 Excimer Laser System
- Generic name
- Excimer laser system
- Applicant
- Nidek Co., Ltd.
- Date received
- 2017-07-17
- Decision date
- 2018-01-12
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gamagori
- Statement
- Approval for the change of laser head of the excimer laser, software upgrade to accommodate the laser head change, change of the PC and change to the power transformer.
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