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Biolase, Inc.

USA · Irvine

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

8registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 1Class 2b 2

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 10 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia8 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Biolase, Inc

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210183	Waterlase iPLus	2022-04-21
US	K213428	EdgePro	2021-12-22
US	K193486	Epic 980	2020-03-16
SA	ME0000015116SFDAA00001	Diode Laser System Surgical Handpiece	—
SA	ME0000015116SFDAA00005	Deep Tissue Handpiece Disposable Shields	—

Biolase, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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