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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 laser system beam guide, single-use, non-sterile FDA UDI
Device Name
A non-sterile, single-use fiberoptic tip accessory intended for use with Biolase diode laser systems. FDA UDI
Model / Reference
E2-20 EZ Tips FDA UDI
Description
A non-sterile, single-use fiberoptic tip accessory intended for use with Biolase diode laser systems. FDA UDI

Identifiers

Primary DI / UDI-DI
00647529000311 FDA UDI
510(k) Number
K121286 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical laser system beam guide, single-use, non-sterile 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 20 Millimeter FDA UDI
Outer Diameter — 200 Micrometer FDA UDI

Category: General/multiple surgical laser system beam guide, single-use, non-sterile

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

Similar devices

Also classified as General/multiple surgical laser system beam guide, single-use, non-sterile.

Cleared under the same submission

K121286 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biolase, Inc.

Sources (1)

  • FDA UDI a740bb93-dd0a-40ff-b4cc-8d7af1ab91be 36 fields · synced Jun 8, 2026