FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S067
·
Decision Aug 9, 2024
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System
- PMA Number
- P930016
- Supplement Number
- S067
- 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
- August 9, 2024
- Date Received
- July 12, 2024
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P930016/S053.
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 |