FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S051
·
Decision Jul 14, 2017
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- Star S4 IR Excimer Laser System
- PMA Number
- P930016
- Supplement Number
- S051
- 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
- July 14, 2017
- Date Received
- May 16, 2017
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the replacement of the existing photo interrupter (3703-0124, manufactured by Hamamatsu) in the BSM Flex assembly (0030-1275) used in the Beam Shaping Module (BSM) assembly (0030-2162) of the STAR S4 IR, with a replacement photo interrupter (3703-0157-L, manufactured by Sharp Microelectronics).
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 |