Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
- PMA Number
- P930034
- 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
- February 5, 1997
- Date Received
- December 26, 1995
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO USE LASER VISION CORRECTION OR LVC AS A SYNONYM FOR PHOTOREFRACTIVE KERATECTOMY OR PRK IN YOUR LABELING. THE APPLICATION IS APPROVED SUBJECT TO THE CONDITION THAT LVC WILL NOT BE USED IN THE FOLLOWING INSTANCES: 1)IN ADS TO PRACTITIONERS; 2)IN SECTION THAT CONTAIN THE APPROVED INDICATION, CONTRAINDICATION, WARNING, PRECAUTION, CAUTION, AND "A-J" STATEMENTS IN THE FDA APPROVAL ORDER DATED OCTOBER 20, 1995; 3) ON THE TITLE PAGE OF THE PATIENT INFORMATION BOOKLET; 4) AT THE BEGINNING OF TEXT IN A BOOKLET OR AN AD, UNTIL THE TERM "LASER VISION CORRECTION (LVC)" IS DEFINED AS A REPLACEMENT FOR PRK; AND 5) WHEN DISTINGUISHING THE VARIOUS SURGERIES, E.G., PTK AND PRK (NOT LVC).
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 |