Medical Device Manufacturer · US , Irvine , CA

Biolase, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2014
10
Total
10
Cleared
0
Denied

FDA 510(k) cleared devices by Biolase, Inc. General & Plastic Surgery ✕

9 devices
1-9 of 9
Cleared Apr 21, 2022
Waterlase iPLus
K210183 · GEX
General & Plastic Surgery · 451d
Cleared Mar 16, 2020
Epic 980
K193486 · GEX
General & Plastic Surgery · 90d
Cleared Dec 04, 2019
Epic 980
K192430 · GEX
General & Plastic Surgery · 90d
Cleared Oct 10, 2019
Waterlase Laser System Family
K190319 · GEX
General & Plastic Surgery · 239d
Cleared Nov 29, 2017
Epic Pro 940
K172771 · GEX
General & Plastic Surgery · 76d
Cleared Jan 11, 2017
Epic Pro
K163128 · GEX
General & Plastic Surgery · 64d
Cleared Jul 28, 2016
Waterlase Express
K161669 · GEX
General & Plastic Surgery · 42d
Cleared Mar 05, 2015
WATERLASE IPLUS S
K141975 · GEX
General & Plastic Surgery · 227d
Cleared Oct 10, 2014
EPIC 10
K140120 · GEX
General & Plastic Surgery · 267d
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