DISHLER EXCIMER LASER SYSTEMS
FDA premarket approval P970049 · decided 1999-12-16
Approval details
- PMA number
- P970049
- Trade name
- DISHLER EXCIMER LASER SYSTEMS
- Applicant
- Dtc Eye Surgery Center
- Date received
- 1997-10-06
- Decision date
- 1999-12-16
- Days to decision
- 801 days
- Decision code
- APWD
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Englewood, CO
- Statement
- Approval for LASIK in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from -0.5 to -13.0 diopters (D) MRSE (manifest refraction spherical equivalence) with or without -0.5 D to - 4.0 D astigmatism; and in patients with documented evidence of changes refraction of less than or equal to 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of preoperative examination.
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