FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P970043
·
Supplement: S003
·
Decision May 12, 1999
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LADAR VISION EXCIMER LASER SYSTEM
- PMA Number
- P970043
- 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
- May 12, 1999
- Date Received
- April 16, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for labeling changes (i.e., minor editorial changes and the addition of a precaution statement to the Patient Information Booklet, Physicians' Booklet, and System Operation Manual. The System Operation Manual also included some revised instructions for use, including directions to follow in the event of a power interruption before or during 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 |