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Diode Laser System Deep Tissue Handpiece

FDA UDI

Class II (US FDA UDI)

by Biolase, Inc.

Identity

Trade Name
Diode Laser System Deep Tissue Handpiece FDA UDI
Generic Name
Musculoskeletal/physical therapy laser, professional FDA UDI
Device Name
A reusable topical heating device intended for use with Diode Laser Systems in pain therapy. The device is used with disposable protective shields. FDA UDI
Model / Reference
6400311 Refurbished FDA UDI
Description
A reusable topical heating device intended for use with Diode Laser Systems in pain therapy. The device is used with disposable protective shields. FDA UDI

Identifiers

Primary DI / UDI-DI
00647529002537 FDA UDI
510(k) Number
K121286 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal/physical therapy laser, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Diode Laser System Deep Tissue Handpiece 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 a402eac0-2f8c-449b-b594-cc851c58aef6 36 fields · synced May 30, 2026