VisuMax Femtosecond Laser 510(k) FDA Approval

Device	VisuMax Femtosecond Laser
Generic Name	Femtosecond Laser System For Refractive Correction
Applicant	Carl Zeiss Meditec, Inc.5160 Hacienda Drivedublin, CA 94568 PMA NumberP150040 Supplement NumberS011 Date Received11/22/2022 Decision Date12/21/2022 Product Code OTL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received	2022-11-22
Decision Date	2022-12-21
PMA	P150040
Supplement	S011
Product Code	OTL
Advisory Committee	Ophthalmic
Supplement Type	30-day Notice
Supplement Reason	Process Change - Manufacturer/sterilizer/packager/supplier
Expedited Review	No
Combination Product	No
Applicant Address	Carl Zeiss Meditec, Inc. 5160 Hacienda Drive dublin, CA 94568 PMA NumberP150040 Supplement NumberS011 Date Received11/22/2022 Decision Date12/21/2022 Product Code OTL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Qualify An Additional Manufacturing Site For The Supplier Of The Contact Glass Used In The Treatment Pack Accessory

VisuMax Femtosecond Laser