LASERVISION/VISX EXCIMER LASER MODEL C
FDA premarket approval P960019 · decided 1996-11-15
Approval details
- PMA number
- P960019
- Trade name
- LASERVISION/VISX EXCIMER LASER MODEL C
- Generic name
- Excimer laser system
- Applicant
- Laser Vision Centers, Inc.
- Date received
- 1996-06-03
- Decision date
- 1996-11-15
- Days to decision
- 165 days
- Decision code
- APWD
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- St. Louis, MO
- 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 INFECT
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