FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S003
·
Decision Apr 24, 1997
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- VISX EXCIMER LASER SYSTEM MODELS B AND C
- PMA Number
- P930016
- Supplement Number
- S003
- 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
- April 24, 1997
- Date Received
- August 26, 1996
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- Y
- Docket Number
- 97M-0084
Advisory Committee Statement
APPROVAL FOR THE VISX EXCIMER LASER SYSTEM (MODELS B & C). THIS DEVICE IS INDICATED FOR MYOPIC ASTIGMATIC PHOTOREFRACTIVE KERATECTOMY (PRKA) USING AN ABLATION ZONE WITH A 6.0 MM MAJOR AXIS
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 |