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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
An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns and different lenghts. The tips are non-sterile for single use only and require sterilization prior to use. FDA UDI
Model / Reference
Diode Laser Tips - Starter Kit FDA UDI
Description
An assortment kit containing a combination of uninitiated and pre-initiated laser tips intended for use with Biolase diode lasers only. The tips have the same core diameter of 400 microns and different lenghts. The tips are non-sterile for single use only and require sterilization prior to use. FDA UDI

Identifiers

Catalog Number
6400165 FDA UDI
Primary DI / UDI-DI
00647529004005 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
Not 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

Yes

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 — 9 Millimeter FDA UDI
Length — 7 Millimeter FDA UDI
Length — 4 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

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 2cb0a355-883d-4ab6-bf0a-1f797f42f645 38 fields · synced Jun 6, 2026