K-number	K190319
Device name	Waterlase Laser System Family
Applicant	Biolase, Inc.
Product code	GEX
Device class	Class II
Decision date	Oct 10, 2019
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Waterlase Laser System Family

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