NIDEK EXCIMER LASER SYSTEM EC-5000
FDA premarket approval P970053/S013 · decided 2014-11-21
Approval details
- PMA number
- P970053
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NIDEK EXCIMER LASER SYSTEM EC-5000
- Generic name
- Excimer laser system
- Applicant
- Nidek Co., Ltd.
- Date received
- 2014-02-11
- Decision date
- 2014-11-21
- Days to decision
- 283 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gamagori
- Statement
- APPROVAL TO USE THE OPD-SCAN III ABERROMETER AND UPDATE THE FINAL FIT SOFTWARE (V1.11 TO 1.12) TO FACILITATE COMPATIBILITY WITH A NEW ABERROMETER TO PERFORM TOPOGRAPHY-GUIDED LASER IN-SITU KERATOMILEUSIS (LASIK).
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