PMA P060004S006

Device: MEL90
Applicant: Carl Zeiss Meditec, Inc.
PMA number: P060004
Supplement: S006
Product code: LZS
Decision date: 2024-12-04
Classification: Ophthalmic
Generic name: Excimer laser system
Approval order statement: This device is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of:• Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D;• Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and• Mixed astigmatism with cylinder from >1.00 D up to 4.00 D;in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50

Current openFDA PMA Record#

Device: MEL90
Applicant: Carl Zeiss Meditec, Inc.
PMA number: P060004
Supplement: S006
Product code: LZS
Generic name: Excimer laser system
Decision date: 2024-12-04
Decision code: APPR
Date received: 2023-08-21
Supplement type: Panel Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: This device is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of:• Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D;• Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and• Mixed astigmatism with cylinder from >1.00 D up to 4.00 D;in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50