FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P020050
·
Supplement: S013
·
Decision May 15, 2013
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- WAVELIGHT EX500 EXCIMER LASER SYSTEM
- PMA Number
- P020050
- 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
- May 15, 2013
- Date Received
- April 17, 2013
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE LABELING CHANGES OF WAVELIGHT® EX 500 EXCIMER LASER SYSTEM AND WAVELIGHT LASER SYSTEM.
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 |