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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 30 single-use pre-initiated tips intended for use with diode laser delivery systems. The tips vary in length and core diameter. FDA UDI
Model / Reference
EpiTips Surgical Assortment FDA UDI
Description
An assortment kit containing 30 single-use pre-initiated tips intended for use with diode laser delivery systems. The tips vary in length and core diameter. FDA UDI

Identifiers

Catalog Number
6400564 FDA UDI
Primary DI / UDI-DI
00647529001967 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

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 c5dc6343-7e04-4a2c-b48d-d6791370ae60 37 fields · synced May 30, 2026