NANOLITE SKIN CARE SYSTEM

K061117 · Nanolite Technology, Inc. · GEX · Jun 20, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061117
• Device Name: NANOLITE SKIN CARE SYSTEM
• Applicant: Nanolite Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 20, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Nanolite Skin Care System is indicated to treat pigmented lesions.

Device Story

Nanolite Skin Care System is a light-based device using LEDs to stimulate and regenerate skin cells. Input: electrical power. Transformation: device delivers red light at 640 nm via LED module; software controls output power to 170 mW/cm² per LED (total 1020 mW/cm²) to achieve a standard dose of approximately 90J/cm² per treatment. Operation: base unit with power supply, adjustable arm, and LCD touchscreen control unit. Software cycles lights on/off during 20-minute sessions to prevent skin desensitization and enhance stimulative effects. Used in clinical settings for dermatological treatment. Output: therapeutic red light exposure. Benefit: treatment of pigmented lesions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Light-based device using surface mount LED modules. Wavelength: 640 nm. Output: 170 mW/cm² per LED; 1020 mW/cm² total power dissipation. Dose: ~90J/cm². Components: base with power supply, adjustable arm, LCD touchscreen control unit. Software-controlled duty cycle for light pulsing.

Indications for Use

Indicated for the treatment of pigmented lesions in patients.

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

• Omnilux Revive (K030426)

Submission Summary (Full Text)

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## JUN 20 2006

## 510(k) Summary of Safety and Effectiveness

Applicant: Nanolite Technology, Inc.

Address: 21250 Hawthorne Blvd., Suite 500 Torrance, California 90503

Phone: [phone]

Fax: [phone]

Contact Person: Hueng Khon Kim

Summary Preparation Date: May 17, 2006

Device Trade Name: Nanolite Skin Care System

Device usual name: Low level light therapy device

Device Classification:

Regulatory Class: Class II

Product Code: GEX

Classification Panels: General and Plastic Surgery

Regulation Number: 21 C.F.R. 878.4810 (Laser surgical instrument for use in general and plastic surgery and in dermatology)

Note: The Nanolite Skin Care System is not a laser product; however, the applicant believes that this classification is the most applicable.

Description of the Device:

The Nanolite Skin Care System is a light-based device that uses LED to stimulate and regenerate skin cells. The device delivers red light at 640 nm.

The principal parts of the device are: the base that contains the power supply; a LED module containing surface mount device chip LEDs; one arm attached to the LED module to be positioned for patient treatment; and a control unit consisting of an LCD panel with a touchscreen display.

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The software in the LCD panel is preprogrammed to provide for twenty minutes of exposure time to LED lights per treatment. During each treatment, the lights are turned on and off to prevent desensitization of the skin area that is being treated and to increase the stimulative effects of the energy from the LED.

The Nanolite Skin Care System generates output power equal to 170 mW/cm² from each LED. Since Nanolite has 6 LEDs per square centimeter, it generates total power dissipation per square meter of 1020 mW/cm². The device software is programmed to control the output power to create a standard dose of approximately 90J/cm² tho each treatment.

Predicate Devices:

The Nanolite Skin Care System is substantially equivalent to Omnilux Revive manufactured by Photo Therapeutics Limited (K030426).

Indications:

The Nanolite Skin Care System is indicated to treat pigmented lesions.

Substantial Equivalence:

The Nanolite Skin Care System and the predicate device are all light devices that use light emitting diodes to treat dermatological conditions by exposing the surface of the skin to light at precise wavelengths. They have the same intended use and general indications for use, are similarly designed, and have similar principles of operation, performance and technological characteristics. Although there are some differences in the technological characteristics of the Nanolite Skin Care System and its predicate devices, those differences do not raise new questions of safety or efficacy. Therefore, the Nanolite Skin Care System is substantially equivalent.

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JUN 20 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nanolite Technology, Inc. c/o Daniel W. Lehtonen Intertek Testing Services 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087

Re: K061117 Trade/Device Name: Nanolite Skin Care System™ 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 2, 2006 Received: June 5, 2006

Dear Mr. Lehtonen:

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.

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. Daniel W. Lehtonen

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 240-276-0115. 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/industry/support/index.html.

Sincerely yours,

Herber Hemus us

Mark N. Melkerson 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: K061117

Device Name: Nanolite Skin Care System™

Indications for Use:

The Nanolite Skin Care System is indicated to treat pigmented lesions.

Prescription Use _ X (per 21 CFR 801.109)

ﻟﻜﻢ

OR

Over-the-Counter Use

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

Hulus Resmer

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

06 111 510(k) Number_