Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LASERVISION/VISX EXCIMER LASER MODEL C
- PMA Number
- P960019
- 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- Approved (Withdrawn)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
- November 15, 1996
- Date Received
- June 3, 1996
- Expedited Review
- N
- Docket Number
- 97M-0256
Advisory Committee Statement
DEVICE INDICATED FOR: 1)PTK IN PATIENTS W/DECREASED BEST CORRECTED VISUAL ACUITY AND/OR WITH DISABLING PAIN THAT ARE THE RESULT OF SUPERFICIAL CORNEAL EPITHELIAL IRREGULARITIES OR STROMAL SCARS IN THE ANTERIOR ONE-THIRD OF THE CORNEA. THE PATIENTS MUST HAVE FAILED W/ALTERNATIVE TREATMENT OPTIONS. FOR SAFETY, THE IMMEDIATE POSTOPERATIVE CORNEAL THICKNESS MUST NOT BE LESS THAN 250 MICRONS. EXAMPLES OF THOSE CONDITIONS THAT WARRANT PTK ARE: A)CORNEAL SCARS & OPACITY (FROM TRAUMA AND INACTIVE INFECTIONS), B)DYSTROPHIES (REIS-BUCKLER'S, GRANULAR AND LATTICE), C)THYGESON'S SUPERFICIAL KERATITIS, D) IRREGULAR CORNEAL SURFACES ASSOCIATED W/FILAMENTARY KERATITIS AND SALZMANN'S NODULAR DEGENERATION, E)RESIDUAL BAND KERATOPATHY AFTER UNSUCCESSFUL EDTA TREATMENT, AND, F)SCARS SUBSEQUENT TO PREVIOUS (NOT CONCURRENT) PTERYGIUM EXCISION. 2)PRK FOR A 6.0 ABLATION ZONE IN PATIENTS WHO ARE MYOPIC AND MEET ALL OF THE FOLLOWING CRITERIA: 1)1.0 TO 6.0 DIOPTERS (D) OF MYOPIA WITH ASTIGMATISM OF 2.0 DIOPTERS; B)REFRACTIVE CHANGE IS WITHIN 0.5D FOR ONE YEAR PRIOR TO THE LASER TREATMENT; AND C)18 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 |