FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S001
·
Decision Oct 15, 1996
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
- S001
- 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
- October 15, 1996
- Date Received
- April 18, 1996
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
LABELING CHANGES (I.E., MINOR EDITORAL CHANGES TO THE PATIENT INFORMATION BOOKLET, CONTRAST SENSITIVITY/GLARE PRECAUTIONARY STATEMENT IN LIEU OF A POSTAPPROVAL CONTRAST SENSITIVITY STUDY, AND DEFINITIONS OF POTENTIAL RISKS WITH PRK)
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 |