PLASMALUXLS

K100628 · Daavlin Distributing Co. · ONE · Nov 24, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100628
• Device Name: PLASMALUXLS
• Applicant: Daavlin Distributing Co.
• Product Code: ONE · General, Plastic Surgery
• Decision Date: Nov 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PlasmaLuxLS is a medical light source, which is intended for use for the treatment of moderate acne vulgaris with blue light.

Device Story

PlasmaLuxLS is a compact light therapy device delivering blue light at a 417 nm peak wavelength. Operated by a physician or under physician direction, the device provides local area phototherapy for moderate inflammatory acne vulgaris. The operator selects the treatment dose via a front-panel interface; lamps then deliver the specified light dose to the patient. The device is intended for clinical use. It functions as a non-coherent light source, providing a uniform distribution of light to the treatment area.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Compact light source; delivers non-coherent blue light at 417 nm peak wavelength. Utilizes materials of identical composition to predicate devices. Operated via front-panel interface for dose selection. No specific software algorithm or connectivity features described.

Indications for Use

Indicated for the treatment of moderate inflammatory acne vulgaris in patients under the direction of a physician.

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

• DUSA Pharmaceuticals, Inc. BLU-U Blue Light Photodynamic Therapy Illuminator Model 4170 (K031805)

Reference Devices

• Lynton Lasers Limited Light Source (K062871)
• LumaCare LC-122-M Non-coherent (K083586)
• LIGHTWAVE Technologies LLC Lightwave Professional Deluxe (K083586)

Submission Summary (Full Text)

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K100628 pg. 1 of 2

NOV 2 4 2010

# 510(k) Summary

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The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

| Submitter's Name: | The Daavlin Distributing Company |
|------------------------|-----------------------------------------------------------------------------------------|
| Registration Number: | 1526255 |
| Address: | 205 West Bement Street<br>Bryan, Ohio 43506 |
| Telephone: | 419.636.6304 |
| Contact: | Michele Thiel |
| Date Prepared: | March 2, 2010 |
| Device Trade Name: | PlasmaLuxLS |
| Device Common Name: | Light Therapy Device |
| Device Classification: | Class II |
| Product Code: | ONE |
| Regulation Number: | CFR 878.4810, 890.5500 |
| Regulation Name: | Laser surgical instrument for use in General and Plastic surgery<br>and in Dermatology. |
| Predicate Devices: | DUSA Pharmaceuticals, Inc. |
| | BLU-U Blue Light Photodynamic Therapy Illuminator Model<br>4170<br>K031805 |

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K100628

f 2 of 2

Lynton Lasers Limited Light Source K062871

LumaCare LC-122-M Non-coherent

LIGHTWAVE Technologies LLC Lightwave Professional Deluxe k083586

#### Device Description:

The PlasmaLuxLS is a compact light source that delivers a uniform distribution of light, with spectral output at peak wavelengths of 417 nm (Blue Light) a It is intended for use by or under the direction of a physician for the treatment of moderate acne vulgaris with blue light. The desired dose is selected using the operator interface located on the front panel of the device. The PlasmaLux LS device delivers local area phototherapy, whereby lamps deliver the specified dose of Blue Light.

### Predicate Device Comparison:

The PlasmaLuxLS is constructed in the same design configuration as the predicate devices, utilizing similar energy types and materials of identical composition. The light emitted by the PlasmaLux is of identical spectrum and power as that of the predicate devices. The PlasmaLux can be used with exactly the same treatment regimes as the predicate devices.

### Intended Use:

The PlasmaLuxLS is a medical light source, which is intended for use for the treatment of moderate acne vulgaris with blue light.

### Performance Data:

No Data Provided.

### Conclusion:

On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the PlasmaLuxLS is substantially equivalent to the legally commercialized predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

The Daavlin Distributing Company % Ms. Michele Thiel 205 West Bement Street Bryan, Ohio 43506

Re: K100628

Trade/Device Name: PlasmaLuxLS Regulation Number: 21 CFR 878,4810 Regulation Name: Laser surgical instrument for use in general and Plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONE Dated: October 26, 2010 Received: - November 03, 2010

Dear Ms. Thiel:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

NOV 2 4 2010

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Page 2 – Ms. Michele Thiel

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm.

Sincerely yours,

Mark N. Milkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100628 Pg 1 of 1

# Indication for Use

NOV 2 4 2010

510(k) Number

Device Name PlasmaLuxLS

### Indications for Use

The PlasmaLuxLS is a medical laser device, which is intended for the treatment of moderate inflammatory acne vulgaris.

Prescription Use - X

OR

Over-the-Counter Use _

(per 21 CFR 801.109)

(Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mich A. Milkeron

(Division Sign-Oft) Division . surgical, Orthopedic, and Restorative Devices

510(k) Number