FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P020050
·
Supplement: S029
·
Decision May 11, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- WaveLight EX500 Laser System
- PMA Number
- P020050
- Supplement Number
- S029
- 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 11, 2018
- Date Received
- February 27, 2018
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for Platform Enhancement Refractive Suite Phase I (PERS I) hardware changes (color concept, update to head-up display, keyboard, control panel and console updates), and include software release Green SP4 (SP = Service Pack) with changes to the graphical user interface.
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 |