Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LADAR VISION EXCIMER LASER SYSTEM
- PMA Number
- P970043
- Supplement Number
- S002
- 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
- December 3, 1999
- Date Received
- March 3, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval to modify the current labeling by 1)updating the clinical results with 12-month data; 2)presenting the 12-month data stratified into three groups (low myopia, low myopia with astigmatism, and high myopia with and without astigmatism) based on preoperative refractive error, and 3) including new contrast sensitivity claims based on a contrast sensitivity study of 284 pts. Other modifications to the labeling include editorial changes, the addition of new data tables reformatted to reflect the revised stratification of data, and the inclusion of a revised contrast sensitivity labeling statement to read: "In a constrast sensitivity study designed to assess theeffects of LADARVision surgery on how well patients can see in conditions such as very dim light, rain, snow, fog or glare from bright lights at night, the percentages of patients showing clinically significant losses were 10.6% at 6 months and 6.6% at 12 months after surgery, and the percentages of patients showing clinically significant improvements were 5.9% at 6 months and 3.3% at 12 months after surgery."
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 |