Diode Laser System Whitening Handpiece

FDA UDI

Class II (US FDA UDI)

by Biolase, Inc.

Identity

Trade Name: Diode Laser System Whitening Handpiece FDA UDI
Generic Name: Dental diode laser system FDA UDI
Device Name: Whitening Handpiece is intended for use with Biolase diode laser systems such as Epic X or Epic Pro and LaserWhite20 Whitening Gel for laser-assisted tooth whitening procedures. The handpiece is reusable and requires disinfection prior to use. The handpiece is equipped with with single-use disposable protective shields included in the packaging in a set of 5. FDA UDI
Model / Reference: 7400022 FDA UDI
Description: Whitening Handpiece is intended for use with Biolase diode laser systems such as Epic X or Epic Pro and LaserWhite20 Whitening Gel for laser-assisted tooth whitening procedures. The handpiece is reusable and requires disinfection prior to use. The handpiece is equipped with with single-use disposable protective shields included in the packaging in a set of 5. FDA UDI

Identifiers

Catalog Number: 7400022 FDA UDI
Primary DI / UDI-DI: 00647529000205 FDA UDI
510(k) Number: K121286 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dental diode laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental diode laser system

Diode Laser System Whitening Handpiece by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K121286 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biolase, Inc.

Sources (1)

FDA UDI 093de688-02f2-441c-8231-923a0606e303 36 fields · synced May 30, 2026