FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P030008
·
Supplement: S013
·
Decision Apr 10, 2014
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- WAVELIGHT EX500 EXCIMER LASER SYSTEM
- PMA Number
- P030008
- 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
- April 10, 2014
- Date Received
- January 22, 2014
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN ALTERNATE MODIFIED PATIENT SWIVEL BED FOR USE WITH THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE MODIFICATIONS ALLOW THE PATIENT BED TO BE USED WITH FEMTOSECOND LASERS OTHER THAN THE WAVELIGHT FS200 LASER TO CREATE THE FLAP FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK).
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 |