EZLASE

Powered Laser Surgical Instrument

BIOLASE TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Ezlase.

Pre-market Notification Details

• Device ID: K061898
• 510k Number: K061898
• Device Name: EZLASE
• Classification: Powered Laser Surgical Instrument
• Applicant: BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618
• Contact: Ioana M Rizoiu
• Correspondent: Ioana M Rizoiu; BIOLASE TECHNOLOGY, INC. 4 CROMWELL Irvine, CA 92618
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-03
• Decision Date: 2007-01-26
• Summary: summary