FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P020050
·
Supplement: S002
·
Decision Feb 15, 2005
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- ALLEGRETTO WAVE EXCIMER LASER SYSTEM
- PMA Number
- P020050
- Supplement Number
- S002
- 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
- February 15, 2005
- Date Received
- January 31, 2005
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR NOTEBOOK SOFTWARE CHANGES TO THE NEW SOFTWARE VERSION (NB-042201) THAT INVOLVE: 1) A CHANGE IN THE NOTATION USED TO ENTER REFRACTION; AND 2) THE SOFTWARE MENU LOCATION AT WHICH USERS MAY SELECT DIFFERENT VALUES FOR FLAP THICKNESS BASED ON THE TYPE OF MICROKERATOME USED TO CREATE CORNEAL FLAPS.
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 |