FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P970053
·
Supplement: S017
·
Decision Jan 12, 2018
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
- S017
- 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
- January 12, 2018
- Date Received
- July 17, 2017
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the change of laser head of the excimer laser, software upgrade to accommodate the laser head change, change of the PC and change to the power transformer.
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 |