WATERLASE

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 Waterlase.

Pre-market Notification Details

• Device ID: K031140
• 510k Number: K031140
• Device Name: WATERLASE
• 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
• Subsequent Product Code: DZI
• Subsequent Product Code: MXF
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-10
• Decision Date: 2004-07-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00647529003008	K031140	000
00647529000243	K031140	000
00647529002803	K031140	000
00647529002810	K031140	000
00647529002827	K031140	000
00647529003039	K031140	000
00647529003046	K031140	000
00647529003053	K031140	000
00647529003060	K031140	000
00647529002797	K031140	000
00647529002780	K031140	000
00647529003015	K031140	000
00647529002681	K031140	000
00647529001110	K031140	000
00647529002742	K031140	000
00647529001134	K031140	000
00647529001165	K031140	000
00647529002766	K031140	000
00647529001172	K031140	000
00647529003077	K031140	000
00647529003084	K031140	000
00647529003091	K031140	000
00647529002926	K031140	000
00647529002988	K031140	000
00647529002933	K031140	000
00647529002940	K031140	000
00647529002957	K031140	000
00647529002964	K031140	000
00647529002971	K031140	000
00647529002995	K031140	000
00647529002919	K031140	000
00647529002902	K031140	000
00647529001318	K031140	000
00647529001325	K031140	000
00647529002841	K031140	000
00647529001370	K031140	000
00647529001387	K031140	000
00647529002872	K031140	000
00647529002889	K031140	000
00647529002896	K031140	000
00647529003022	K031140	000