TWILIGHT

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 Twilight.

Pre-market Notification Details

• Device ID: K991994
• 510k Number: K991994
• Device Name: TWILIGHT
• Classification: Powered Laser Surgical Instrument
• Applicant: BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673
• Contact: Ioana M Rizoiu
• Correspondent: Ioana M Rizoiu; BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente, CA 92673
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-14
• Decision Date: 1999-09-10
• Summary: summary