FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S018
·
Decision Jun 7, 2004
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
- PMA Number
- P930016
- Supplement Number
- S018
- 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
- June 7, 2004
- Date Received
- December 15, 2003
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR SOFTWARE UPGRADE: WAVESCAN SOFTWARE VERSION 3.5 CHANGES FROM CURRENTLY APPROVED VERSION 3.07 (UNDER P930016/S016) FOR VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM FOR WAVEFRONT-GUIDED LASIK TREATMENTS OF MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D.
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 |