FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P990027
·
Supplement: S016
·
Decision Jan 26, 2011
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- TECHNOLAS 217Z ZYOPTIX SYSTEM
- PMA Number
- P990027
- Supplement Number
- S016
- 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
- January 26, 2011
- Date Received
- September 17, 2010
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR 1) A SINGLE PART HARD DISK DRIVE; 2) AN ADDITIONAL CALIBRATION TOOL; 3) CHANGE THE SPUTTER PROCESS OF THE APERTURE; AND 4) PRODUCTION OF THE HIGH PRESSURE UNIT AND ASSOCIATED TESTING OUTSOURCED TO A NEW SUPPLIER.
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 |