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 IDK031140
510k NumberK031140
Device Name:WATERLASE
ClassificationPowered Laser Surgical Instrument
Applicant BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente,  CA  92673
ContactIoana M Rizoiu
CorrespondentIoana M Rizoiu
BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente,  CA  92673
Product CodeGEX  
Subsequent Product CodeDZI
Subsequent Product CodeMXF
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-10
Decision Date2004-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00647529003008 K031140 000
00647529000243 K031140 000
00647529002803 K031140 000
00647529002810 K031140 000
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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

Trademark Results [WATERLASE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WATERLASE
WATERLASE
76136329 2660361 Live/Registered
BIOLASE, INC.
2000-09-26

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