FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P990027
·
Decision Feb 23, 2000
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
- PMA Number
- P990027
- 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 23, 2000
- Date Received
- May 28, 1999
- Expedited Review
- N
- Docket Number
- 00M-1597
Advisory Committee Statement
APPROVAL FOR THE TECHNOLAS(R) 217A EXCIMER LASER SYSTEM. THE DEVICES IS INDICATED TO PERFORM LASER IN-SITU KERATOMILEUSIS (LASIK): 1) IN TREATMENTS FOR THE REDUCTION OR ELIMINATINO OF MYOPIA (NEARSIGHTEDNESS) FROM -1.00 TO -7.00 DIOPTERS D WITH LESS THAN -3.00 D ASTIGMATISM; 2) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS AS DEMONSTRATED BY A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS); AND, 3) IN PATIENTS 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 |