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FDA 510(k) Applications Submitted by BIOLASE, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190319
02/13/2019
Waterlase Laser System Family
Biolase, Inc.
K161669
06/16/2016
Waterlase Express
Biolase, Inc.
K192430
09/05/2019
Epic 980
Biolase, Inc.
K140120
01/16/2014
EPIC 10
BIOLASE, INC.
K141975
07/21/2014
WATERLASE IPLUS S
BIOLASE, INC.
K210183
01/25/2021
Waterlase iPLus
Biolase, Inc.
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