FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S049
·
Decision Jan 11, 2017
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- STAR EXCIMER LASER SYSTEM
- PMA Number
- P930016
- Supplement Number
- S049
- 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
- January 11, 2017
- Date Received
- December 27, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Revision of the span and zero calibration procedure of the fluorine (F2) sensor of the STAR S4 IR Excimer Laser System according to the sensors manufacturer specification.
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 |