FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P020050
·
Supplement: S032
·
Decision Mar 14, 2019
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- ALLEGRO Topolyzer VARIO and Patient Bed Swivel
- PMA Number
- P020050
- Supplement Number
- S032
- 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
- March 14, 2019
- Date Received
- February 21, 2019
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for a change in labeling to align with the labeling recommendations of IEC 60601-1-2:2014 (4th edition).
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 |