Diode Laser Tips

FDA UDI

Class II (US FDA UDI)

by Biolase, Inc.

Identity

Trade Name: Diode Laser Tips FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: A tip kit containing 2 single-use laser tips intended for use with Epic S-Series laser systems. The tips have the same core diameter of 400 microns and vary in length. FDA UDI
Model / Reference: Surgical EZ Tips FDA UDI
Description: A tip kit containing 2 single-use laser tips intended for use with Epic S-Series laser systems. The tips have the same core diameter of 400 microns and vary in length. FDA UDI

Identifiers

Catalog Number: 7400053 FDA UDI
Primary DI / UDI-DI: 00647529001851 FDA UDI
510(k) Number: K130465 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: General/multiple surgical 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 100 Millimeter FDA UDI
Length — 250 Millimeter FDA UDI
Outer Diameter — 400 Micrometer FDA UDI

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

Cleared under the same submission

K130465 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 ffe1f802-7fd9-4e93-a11b-0ed9e955bf66 38 fields · synced May 30, 2026