FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S008
·
Decision Feb 23, 1999
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- VISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK)
- PMA Number
- P930016
- Supplement Number
- S008
- 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
- February 23, 1999
- Date Received
- September 15, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval to consider report of the postapproval studies a final report and to discontinue all PRK postapproval study requirements. The Model C(STAR) device, as modified in supplement 7, will be marketed under the trade name VISX STAR S2 Excimer Laser System and is indicated for the treatment of myopia, astigmatism and hyperopia (sphere only).
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 |