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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K210183
Device Name Waterlase iPLus
Applicant
Biolase, Inc.
27042 Towne Centre Drive, Suite 270
FootHill Ranch,  CA  92610
Applicant Contact Katy Nennig
Correspondent
Biolase, Inc.
27042 Towne Centre Drive, Suite 270
FootHill Ranch,  CA  92610
Correspondent Contact Katy Nennig
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received01/25/2021
Decision Date 04/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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