FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Excimer Laser System
PMA: P930034
·
Decision Oct 20, 1995
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- SVS APEX EXCIMER LASER SYSTEM
- PMA Number
- P930034
- Device Class
- FDA Class 3
- Product Code
- LZS
- Generic Name
- Excimer laser system
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- October 20, 1995
- Date Received
- October 12, 1993
- Expedited Review
- N
- Docket Number
- 96M-0274
Advisory Committee Statement
INDICATED FOR A 6.0 MM ABLATION ZONE, MYOPIC PHOTOREFRACTIVE KERATECTOMY (PRK) IN PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA:1)1.5 TO 7.0 DIOPTERS OF MYOPIA WITH ASTIGMATISM OF <- 1.5 DIOPTERS; 2)REFRACTION IS WITHIN +- 1.0 DIOPTER FOR ONE YEAR PRIOR TOT HE LASER TREATMENT; AND 3) 21 YEARS OF AGE OR OLDER
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 |