FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P910062
·
Supplement: S001
·
Decision Apr 20, 2000
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
- PMA Number
- P910062
- Supplement Number
- S001
- 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 20, 2000
- Date Received
- April 12, 2000
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
The device, as modified, will be marketed under the trade name VISX STAR S3 Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (PRK) and myopic and astigmatic 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 |