Biolase, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K210183Waterlase iPLusApril 21, 2022
K213428EdgeProDecember 22, 2021
K193486Epic 980March 16, 2020
K192430Epic 980December 4, 2019
K190319Waterlase Laser System FamilyOctober 10, 2019
K172771Epic Pro 940November 29, 2017
K163128Epic ProJanuary 11, 2017
K161669Waterlase ExpressJuly 28, 2016
K141975WATERLASE IPLUS SMarch 5, 2015
K140120EPIC 10October 10, 2014