FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930034
·
Supplement: S012
·
Decision Oct 21, 1999
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- SVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS
- PMA Number
- P930034
- Supplement Number
- S012
- 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
- October 21, 1999
- Date Received
- July 14, 1998
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 00M-0424
Advisory Committee Statement
Approval for the SVS Apex Plus Excimer Laser Workstation, emphasis(R) discs K and L, and axicon. These devices are indicated to perform hyperopic PRK.
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 |