FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930034
·
Supplement: S003
·
Decision Nov 25, 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
- S003
- 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
- November 25, 1996
- Date Received
- March 12, 1996
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Other
- Expedited Review
- N
Advisory Committee Statement
ALL LABELING MUST CONTAIN THE FOLLOWING PRECAUTION STATEMENT: PRECAUTION: ALTHOUGH THE EFFECTS OF PRK ON VISUAL PERFORMANCE UNDER POOR LIGHTING CONDITIONS HAVE NOT BEEN DETERMINED, IT IS POSSIBLE THAT YOU WILL FIND IT MORE DIFFICULT THAN USUAL TO SEE IN CONDITIONS SUCH AS VERY DIM LIGHT, RAIN, SNOW, FOG, OR GLARE FROM BRIGHT LIGHTS AT NIGHT.
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 |