FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P030008
·
Supplement: S024
·
Decision Apr 9, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- Wave Light EX500 Laser
- PMA Number
- P030008
- Supplement Number
- S024
- 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 9, 2018
- Date Received
- January 5, 2018
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for modification of the electronic circuit of VSE (Versorgungseinheit or supply unit) board in the WaveLight EX500 system by adding resistor-capacitor circuits to the switch transistors to reduce the starting currents and improve the reliability and life of the board.
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 |