← Back to catalogue

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 pre-initiated tip intended for use with Biolase diode laser systems. FDA UDI
Model / Reference
EpiTip 4-4 Surgical FDA UDI
Description
A non-sterile, single-use fiberoptic pre-initiated tip intended for use with Biolase diode laser systems. FDA UDI

Identifiers

Primary DI / UDI-DI
00647529000472 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

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
Outer Diameter — 400 Micrometer FDA UDI
Length — 4 Millimeter 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biolase, Inc.

Sources (1)

  • FDA UDI d87fd8a9-2e8d-4c1e-97af-2c8c982c3c0e 37 fields · synced Jun 8, 2026