BLU-U® Blue Light Photodynamic Therapy Illuminator

FDA UDI

Class III (US FDA UDI)

by Dusa Pharmaceuticals, Inc.

Identity

Trade Name: BLU-U® Blue Light Photodynamic Therapy Illuminator FDA UDI
Generic Name: Skin photodynamic therapy/phototherapy lamp FDA UDI
Device Name: The 4170-2 is the Post Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient. FDA UDI
Model / Reference: 4170-2 FDA UDI
Description: The 4170-2 is the Post Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient. FDA UDI

Identifiers

Catalog Number: 4170-2 FDA UDI
Primary DI / UDI-DI: M706417021 FDA UDI
PMA Number: P990019 FDA UDI
FDA Product Code: MVF FDA UDI
GMDN Term: Skin photodynamic therapy/phototherapy lamp FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Skin photodynamic therapy/phototherapy lamp

BLU-U® Blue Light Photodynamic Therapy Illuminator by Dusa Pharmaceuticals, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

P990019 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Dusa Pharmaceuticals, Inc.

Sources (1)

FDA UDI 28a333b6-35bb-44e3-90ae-fff55e9a9f95 37 fields · synced May 31, 2026