FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S056
·
Decision Apr 12, 2019
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System
- PMA Number
- P930016
- Supplement Number
- S056
- 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
- April 12, 2019
- Date Received
- December 31, 2018
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for four edits in engineering drawing of "Beam Splitter, Energy Detector'' and change of the material in the Beam Splitter component of the Energy Detector from Corning Fused Silica Code 7940 to Corning 7980 HPFS.
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 |