PMA P150040S003
- Device
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S003
- Product code
- OTL
- Decision date
- 2018-10-04
- Classification
- Femtosecond Laser System For Refractive Correction
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- Approval for the VisuMax Femtosecond Laser. This device is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism:1) For spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters;2) For cylinder from -0.75 diopters through -3.00 diopters; and3) When refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D in magnitude.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf15/P150040S003B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S003
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2018-10-04
- Decision code
- APPR
- Date received
- 2018-03-23
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the VisuMax Femtosecond Laser. This device is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism:1) For spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters;2) For cylinder from -0.75 diopters through -3.00 diopters; and3) When refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D in magnitude.