FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P970053
·
Supplement: S007
·
Decision Oct 28, 2002
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- PMA Number
- P970053
- Supplement Number
- S007
- 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 28, 2002
- Date Received
- May 23, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF A WINDOWS OPERATING SYSTEM AND EYE TRACKING SYSTEM TO THE NIDEK EC-5000 EXCIMER LASER SYSTEM.
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 |