The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® is generally indicated to treat dermatological indications. The BLU-U® is specifically indicated to treat moderate inflammatory acne vulgaris.

Device Description

The BLU-U® 4170 is a compact light source that delivers a uniform distribution of blue light to the body with a spectral output at a peak wavelength of 417 nm and a Full Width at Half Maximum (FWHM) of 30 nm (407 - 437 nm). The principal parts of the system include the light unit and floor stand with timer.

AI/ML Overview

The provided text is a 510(k) summary for the BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170. It explicitly states that no performance data was required by the FDA for this Class II device, and therefore, no specific acceptance criteria or studies demonstrating device performance against such criteria were submitted.

The basis for clearance was substantial equivalence to a predicate device (ClearLight™ Phototherapy Device, Model CL-420), meaning the FDA determined the new device is as safe and effective as a legally marketed device without needing new clinical studies.

Therefore, the requested information regarding acceptance criteria and studies demonstrating performance against those criteria cannot be extracted from this document, as it was not part of the submission.

Here is a summary of why the requested information is not available in the provided text:

A table of acceptance criteria and the reported device performance: Not applicable. The document states, "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."
Sample size used for the test set and the data provenance: Not applicable. No test set was used for performance evaluation as no performance data was required.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was used.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring ground truth adjudication was used.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a light therapy device, not an AI-assisted diagnostic tool involving human readers. No such study was conducted or required.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a light therapy device, not an algorithm.
The type of ground truth used: Not applicable. No performance data requiring ground truth was generated.
The sample size for the training set: Not applicable. This device is a light therapy device, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable. No training set was used.

Summary

{0}------------------------------------------------

031805 1/2

SEP - 9 2003

D U S λ®

WILMINGION MA 01887

TEL 978.657.7500

1 :: 978 657 9193 /www.Dusapharma.com

510(k) SUMMARY

DUSA Pharmaceuticals, Inc. Applicant & Submitter: 25 Upton Drive Address: Wilmington, MA 01887 978-657-7500 Phone: 978-657-9193 FAX: Contact Person: Scott Lundahl Preparation Date: June 9, 2003 BLU-U® Blue Light Photodynamic Therapy Device Submitted: Illuminator Model 4170 BLU-U® Proprietary Name: Blue Light Therapy Device Common Name: Laser surgical instrument for use in General and Classification Name: Plastic Surgery and in Dermatology. Product Code GEX ClearLight™ Phototherapy Device, Model CL-420 Predicate Device: The BLU-U® 4170 is a compact light source that Device Description: delivers a uniform distribution of blue light to the body with a spectral output at a peak wavelength of 417 nm and a Full Width at Half Maximum (FWHM) of 30 nm (407 - 437 nm). The principal parts of the system include the light unit and floor stand with timer. The BLU-U® Blue Light Photodynamic Therapy Intended Use: Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® 4170 is generally indicated to treat dermatological The BLU-U® 4170 is specifically indications. indicated to treat moderate inflammatory acne vulgaris.

{1}------------------------------------------------

No performance data is required for this Class II Performance Data: device nor requested by the Food and Drug Administration (Office of Device Evaluation). The BLU-U has the same spectral output, mode of operation, treatment area, and general operating principals as well as the same intended use, the same general and specific indications for use as the predicate device. A data base search has been performed to evaluate any adverse effects of the device that is currently marketed. for 807.92 No data submitted section 6[(b)(1)(2)(3c)] The Model 4170 BLU-U® Photodynamic Therapy Substantial Equivalence: Illuminator is substantially equivalent to the previously cleared ClearLight™ Phototherapy Device, Model CL 420. The BLU-U has the same intended use and has the same general and specific indications for use as the Clearlight™. The spectral output, mode of operation, treatment area, and general operating principals for the BLU-U® are similar to or the same as the Clearlight™. The BLU-U® and the ClearLight™ are both light devices that are used to treat dermatological conditions by exposing the surface of the skin to light at precise wavelengths. Although there are some differences in method by which each device produces light. these differences do not raise new question of safety or Thus, the BLU-U® is substantially efficacy. equivalent.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its head facing left. The eagle is composed of three curved lines that suggest feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2003

Mr. Scott Lundahl Director of Regulatory Affairs (Acting) DUSA Pharmaceuticals, Inc. 25 Upton Drive Wilmington, Massachusetts 01887

Re: K031805 Trade/Device Name: BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 9, 2003 Received: June 11, 2003

Dear Mr. Lundahl:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Mr. Scott Lundahl

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number: K031805
(if known)

BLU-U® Blue Light Photodynamic Therapy Illuminator Device Name: Model 4170

The BLU-U® Blue Light Photodynamic Therapy Indications for Use: Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® is generally indicated to treat dermatological indications. The BLU-U® is specifically indicated to treat moderate inflammatory acne vulgaris.

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE OF ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K631805

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.