NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA premarket approval P970053/S012 · decided 2012-12-12
Approval details
- PMA number
- P970053
- Supplement
- S012
- 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
- 2012-09-25
- Decision date
- 2012-12-12
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gamagori
- Statement
- APPROVAL FOR REPLACEMENT OF THE LASER DIODE FOR THE AIMING BEAM, THECORRESPONDING MODIFICATION OF THE AIMING BEAM OPTICAL SYSTEM, AND ASSOCIATED LABELING CHANGES.
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