EC-5000 EXCIMER LASER SYSTEM
FDA premarket approval P970053/S003 · decided 2000-10-25
Approval details
- PMA number
- P970053
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EC-5000 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Nidek Co., Ltd.
- Date received
- 2000-04-28
- Decision date
- 2000-10-25
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gamagori
- Statement
- APPROVAL FOR THE INCORPORATION OF THE NOMOGRAM FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS INTO THE NIDEK EC-5000 SOFTWARE, ALONG WITH THE NOMOGRAM FOR PRK FOR MODERATE MYOPIA WITH ASTIGMATISM.
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510(k) clearances by this applicant
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