LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC

K101190 · Led Intellectual Properties, LLC · OHS · Jul 1, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101190
• Device Name: LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
• Applicant: Led Intellectual Properties, LLC
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Jul 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Light for Wrinkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.

Device Story

Hand-held device; utilizes LED array emitting 605nm, 630nm, 660nm, and 855nm wavelengths; power output 65mW/cm2. User-operated; intended for home use. Device consists of HIPS plastic handle, LED array on printed circuit board, single on/off switch, and external 9-volt AC/DC power supply. User applies device directly to skin for 3-minute treatment sessions. No automated processing or software-based analysis; device functions as a light-delivery system for cosmetic wrinkle reduction.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on identical technological characteristics and design to the predicate device.

Technological Characteristics

Hand-held LED array; wavelengths: 605nm, 630nm, 660nm, 855nm; power output: 65mW/cm2. Materials: HIPS plastic handle, glass polymer LEDs. Power: 9-volt AC to DC supply. Non-sterile. No software or algorithm.

Indications for Use

Indicated for the treatment of periorbital wrinkles in an Over-The-Counter (OTC) setting.

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

• Anti-Wrinkle Light, Model AAL (LED Intellectual Properties, LLC)

Submission Summary (Full Text)

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# 510 (k) SUMMARY K101190

LED Intellectual Properties, LLC.

# Device: Light for Wrinkles

[JUL - 1 2010

1. General Information

Date Updated: June 7, 2010

Submitter: AEGIS Regulatory, Inc. 31 Anthem View Lane Knoxville, TN 37922 Tel.: [phone] Fax: [phone] Contact: Robert T. Wagner Email: [e-mail]

On Behalf of: LED Intellectual Properties, LLC 3189-C Red Hill Ave. Costa Mesa, Ca. 92626 Tel.: [phone] Contact: Steve Marchese Email: [e-mail]

2. Names and Code

Device Proprietary Name: Light for Wrinkles Class Name: Laser Instrument for General and Plastic Surgery Classification Code: OHS, Class II Indications: Light Based Over-The-Counter Wrinkle Reduction

3. Predicate Devices

LED Intellectual Properties, LLC - Anti-Wrinkle Light, Model AAL

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#### 4. Device Description

The Light for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of low intensity light emitting diodes (LED's) that emit Low and Sub-IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.

#### 5. Substantial Equivalency

The Light for Wrinkles has the exact same technological characteristics including design, materials, power output (65nM/cm2), the exact same wavelengths, delivery system and power transformer as the LED Intellectual Properties, LLC - Anti-Wrinkle Light, Model AAL predicate.

### 6. Biocompatibility

The sections of the device that come in contact with the user are the HIPS plastic handle and glass polymer LED's, which are non-sterile and are the same materials as employed on predicate devices.

#### 7. Indications for Use / Intended Use

The Light for Wrinkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.

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# 6. Performance Data

Taking into consideration the statement in"5. Substantial Equivalency" above, after an analysis of the safety, indications and intended uses, performance, features, technological properties and methods of operation, LED Intellectual Properties, LLC believes that no significant differences exist between the Light for Wrinkles and the predicate device listed in Section 3, above.

We request substantially equivalency and OTC variance.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, with three curved lines representing the wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the bird symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL - 1 2010

LED Intellectual Properties, LLC % AEGIS Regulatory, Inc. Mr. Robert T. Wagner 31 Anthem View Lane Knoxville, Tennessee 37922

Re: K101190

Trade/Device Name: Light for Wrinkles 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: OHS Dated: June 07, 2010 Received: June 15, 2010

Dear Mr. Wagner:

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.

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Page 2 - Mr. Robert T. Wagner

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); 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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## Indications for Use

510(k) Number: K101190

Device Name: Light for Wrinkles

Indications For Use:

The Light for Winkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pete Vhmo

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K/0//90