FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P960019
·
Supplement: S002
·
Decision May 5, 1998
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
- PMA Number
- P960019
- 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
- May 5, 1998
- Date Received
- April 17, 1998
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for two add'l indications, myopic astigmatic PRK (PRKa) and high myopia with and without astigmatism for the device. The device, as modified, will be marketed under the trade name MobilExcimer(R) for PTK and PRK. The MobilExcimer(R) for PTK and PRK remains indicated for the indications listed in FDA's letter of 4/27/97 (P960019/S001 and the new indications contained in this supplement.
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 |