FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P970043
·
Supplement: S013
·
Decision Jul 16, 2003
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LADARVISION 4000 EXCIMER LASER SYSTEM
- PMA Number
- P970043
- Supplement Number
- S013
- 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 16, 2003
- Date Received
- July 2, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN EXPANSION OF +- 0.75 D FOR THE ALLOWABLE TARGET OFFSET PARAMETER RANGE FOR THE WAVEFRONT-GUIDED MYOPIC LASIK INDICATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADARVISION 4000 EXCIMER LASER SYSTEM AND IS INDICATED FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE.
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 |