MEL 80 EXCIMER LASER SYSTEM

FDA Premarket Approval P060004 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Change regarding an alternate laser source.

• Device: MEL 80 EXCIMER LASER SYSTEM
• Generic Name: Excimer Laser System
• Applicant: Carl Zeiss Meditec, Inc.
• Date Received: 2008-01-18
• Decision Date: 2008-02-14
• PMA: P060004
• Supplement: S002
• Product Code: LZS
• 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

Supplemental Filings

Supplement Number	Date	Supplement Type
P060004		Original Filing
S002	2008-01-18	30-day Notice
S001	2007-12-28	Panel Track

NIH GUDID Devices

Device ID	PMA	Supp
04049471000221	P060004	001
04049471095074	P060004	006