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BLU-U Blue Light Photodynamic Therapy Illuminator Model 4170E

by Sun Pharmaceutical Industries, Inc. FDA registration: United States 510(k)

510(k) K241358 Product code GEX

Overview

The BLU-U Blue Light Photodynamic Therapy Illuminator Model 4170E is a medical device classified as a photodynamic therapy light source (GEX Product Code). It emits blue light for activating photosensitisers in photodynamic therapy, a non-invasive treatment used to target and destroy abnormal or precancerous cells in the skin. The device is designed to work in conjunction with compatible photosensitisers, such as aminolevulinic acid-based formulations, to induce a photochemical reaction that eliminates targeted tissue.

This illuminator is supplied as a reusable, non-sterile device intended for use in clinical settings, including dermatology offices and surgical suites. It features LED light panels and is regulated under FDA 510(k) clearance (K241358) as a Special Classification device, with a clearance decision dated June 13, 2024. The device is not MRI-compatible and requires proper storage in a clean, dry environment to maintain operational integrity. No additional sterility or single-use specifications are indicated in the regulatory data.

Summary written by AI from registry data, 19 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK241358 Date13 Jun 2024ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Sun Pharmaceutical Industries, Inc.

Questions

  • What types of clinical settings is the BLU-U® Blue Light Photodynamic Therapy Illuminator intended for use in?

    The BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E, is designed for use in clinical settings such as dermatology offices and surgical suites. Its reusable, non-sterile nature makes it suitable for environments where it can be properly cleaned and maintained between uses, ensuring reliable performance for photodynamic therapy procedures.

  • How is the BLU-U® Blue Light Photodynamic Therapy Illuminator supplied, and what does this mean for its use?

    The BLU-U® illuminator is supplied as a reusable, non-sterile device. This means it is intended for repeated use in clinical settings after proper cleaning and maintenance, rather than being discarded after a single procedure. Clinicians must follow manufacturer guidelines to ensure proper disinfection and storage to maintain its functionality and safety.

  • Can the BLU-U® Blue Light Photodynamic Therapy Illuminator be used with an MRI machine, and why?

    No, the BLU-U® Blue Light Photodynamic Therapy Illuminator is explicitly stated as not MRI-compatible. This means it should never be placed in or near an MRI environment, as the magnetic fields and radio waves could potentially damage the device or pose safety risks to patients. Always verify the device’s location relative to MRI equipment.

  • What kind of storage conditions are recommended for the BLU-U® Blue Light Photodynamic Therapy Illuminator?

    The device requires storage in a clean, dry environment to preserve its operational integrity. Since it is reusable and non-sterile, it should be kept in a dedicated space where it can be properly cleaned and stored between uses, away from moisture, extreme temperatures, or contaminants that could affect its performance or longevity.

  • What regulatory pathway was followed for the FDA clearance of the BLU-U® Blue Light Photodynamic Therapy Illuminator?

    The BLU-U® illuminator was cleared through the FDA 510(k) pathway under Special Classification (Product Code GEX) and was determined to be substantially equivalent to a legally marketed predicate device. The clearance decision was made by the General, Plastic Surgery (SU) Advisory Committee on June 13, 2024, with the submission received on May 14, 2024. This process confirms its compliance with U.S. regulatory standards for photodynamic therapy light sources.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K241358 24 fields · synced 22 Oct 2026