Waterlase Express All-Tissue Laser System

FDA UDI

Class II (US FDA UDI)

by Biolase, Inc.

Identity

Trade Name: Waterlase Express All-Tissue Laser System FDA UDI
Generic Name: Dental solid-state laser system FDA UDI
Device Name: An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, and a wireless foot-switch. Other system components include protective eyewear, power cords, tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
Model / Reference: 7210001 FDA UDI
Description: An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, and a wireless foot-switch. Other system components include protective eyewear, power cords, tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI

Identifiers

Catalog Number: 7210001 FDA UDI
Primary DI / UDI-DI: 00647529002339 FDA UDI
510(k) Number: K161669 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dental solid-state laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: Not 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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Waterlase Express All-Tissue Laser System by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K161669 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 f26bd105-8d74-4434-b67e-ed3ae72237ec 38 fields · synced May 30, 2026