FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930034
·
Supplement: S006
·
Decision Oct 22, 1996
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- SVS APEX APEX EXIMER LASER WORKSTATION
- PMA Number
- P930034
- Supplement Number
- S006
- 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 22, 1996
- Date Received
- June 24, 1996
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR DISCONTINUING FURTHER FOLLOW-UP AND REPORT OF THE <6.0 MM SUBJECTS IN ACCORDANCE WITH THE POST APPROVAL REQUIREMENTS
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 |