Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- NIDEK EXCLAIMER LASER SYSTEM EC-5000
- PMA Number
- P970053
- Supplement Number
- S015
- Device Class
- FDA Class 3
- Product Code
- LZS
- Generic Name
- Excimer laser system
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 30, 2015
- Date Received
- October 3, 2014
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE A NEW 1 KHZ EYETRACKER, WHICH REPLACES THE ORIGINAL 200 HZ EYETRACKER USED WITH THE EC-5000 EXCIMER LASER. THIS CHANGE ALSO INCLUDES MODIFICATION TO THE ASSOCIATED CAMERA AND SOFTWARE AS WELL AS THE INFRARED RED (IR) ILLUMINATION. THIS DEVICE IS INDICATED FOR TOPOGRAPHY-ASSISTED LASER- ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENT USING THE FINAL FIT CUSTOM ABLATION TREATMENT PLANNING SOFTWARE FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS FROM -1.0 TO - 4.0 D OF SPHERE WITH ASTIGMATIC REFRACTIVE ERRORS FROM >-0.5 TO -2.0 D AT THE SPECTACLE PLANE; IN PATIENTS 21 YEARS OF AGE OR OLDER; AND, IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN +=0.5 D.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZS | Excimer Laser System | FDA class 3 | Unknown |