BLU-U, MODEL 4170

K031805 · Dusa Pharmaceuticals, Inc. · GEX · Sep 9, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031805
• Device Name: BLU-U, MODEL 4170
• Applicant: Dusa Pharmaceuticals, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

BLU-U® Model 4170 is a compact light source delivering uniform blue light to the body; peak wavelength 417 nm; FWHM 30 nm (407-437 nm). System includes light unit and floor stand with timer. Used in clinical settings by healthcare providers to treat dermatological conditions, specifically moderate inflammatory acne vulgaris, by exposing skin surface to precise wavelengths of light. Output is controlled light exposure; clinical decision-making relies on provider assessment of dermatological condition. Benefits include non-invasive phototherapeutic treatment of acne.

Clinical Evidence

No clinical data submitted. Substantial equivalence based on technological similarities and intended use to the predicate device.

Technological Characteristics

Compact light source; peak wavelength 417 nm; FWHM 30 nm (407-437 nm). Includes light unit and floor stand with timer. Operates as a phototherapeutic light delivery system.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris and other general dermatological conditions.

Regulatory Classification

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.

Predicate Devices

• ClearLight™ Phototherapy Device, Model CL-420

Submission Summary (Full Text)

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031805 1/2

# SEP - 9 2003

D U S λ®

WILMINGION MA 01887

#### TEL [phone]

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: [phone] 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.

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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.

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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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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## 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