FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Excimer Laser System
PMA: P060004
·
Supplement: S005
·
Decision Feb 16, 2023
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- MEL 80 Excimer Laser System
- PMA Number
- P060004
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LZS
- Generic Name
- Excimer laser system
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 16, 2023
- Date Received
- January 23, 2023
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change the glue used on the Fluence Test Card.
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 |