FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P970043
·
Supplement: S025
·
Decision Jul 5, 2006
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM
- PMA Number
- P970043
- Supplement Number
- S025
- 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
- July 5, 2006
- Date Received
- February 1, 2006
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN EXPANSION OF THE ALLOWABLE RANGE FOR THE PHYSICIAN ADJUSTMENT OF DEFOCUS OFFSET PARAMETER FOR THE WAVEFRONT-GUIDED MYOPIA AND MYOPIC ASTIGMATISM INDICATIONS FROM +=0.75 D TO UP TO 1.00 D INCREASE (MORE MYOPIC TREATMENT) AND UP TO 2.50 D DECREASE (LESS MYOPIC TREATMENT).
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 |