iLase Diode Laser System

FDA UDI

Class II (US FDA UDI)

by Biolase, Inc.

Identity

Trade Name: iLase Diode Laser System FDA UDI
Generic Name: Dental diode laser system FDA UDI
Device Name: A diode laser system designed for a variety of dental soft tissue procedures. The system consists of one iLase handpiece and the iLase charging station used for charging and storing the handpiece. Other systems components include protective eyewear, rechargeable batteries, charging station power supply, handpiece cover grips, diode laser tips and a tip cleaning kit. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use. FDA UDI
Model / Reference: iLase Refurbished FDA UDI
Description: A diode laser system designed for a variety of dental soft tissue procedures. The system consists of one iLase handpiece and the iLase charging station used for charging and storing the handpiece. Other systems components include protective eyewear, rechargeable batteries, charging station power supply, handpiece cover grips, diode laser tips and a tip cleaning kit. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use. FDA UDI

Identifiers

Primary DI / UDI-DI: 00647529001332 FDA UDI
510(k) Number: K093852 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: 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

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

Cleared under the same submission

K093852 also covers:

iLase Handpiece — Biolase, Inc.

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 95694eb3-f4a3-4c32-9fe2-5de1a221dd49 36 fields · synced Jun 6, 2026