FIBER ONE

Powered Laser Surgical Instrument

AMERICAN MEDICAL SYSTEMS

The following data is part of a premarket notification filed by American Medical Systems with the FDA for Fiber One.

Pre-market Notification Details

• Device ID: K100746
• 510k Number: K100746
• Device Name: FIBER ONE
• Classification: Powered Laser Surgical Instrument
• Applicant: AMERICAN MEDICAL SYSTEMS 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089
• Contact: Darlene Crockett-billig
• Correspondent: Darlene Crockett-billig; AMERICAN MEDICAL SYSTEMS 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-03-16
• Decision Date: 2010-06-11
• Summary: summary