LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI

K131461 · Led Intellectual Properties, LLC · OLP · Jan 6, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K131461
• Device Name: LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
• Applicant: Led Intellectual Properties, LLC
• Product Code: OLP · General, Plastic Surgery
• Decision Date: Jan 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

LightStim for Acne Mini, model: LS4AM is intended for Over-The-Counter use for the treatment of mild to moderate acne.

Device Story

Hand-held LED device; emits 415nm light for acne treatment. Components: LEDs, hand piece, PCB, on/off switch, resistor, 9V AC/DC power supply. User-controlled treatment time (3-4 minutes per area). Used in home setting by patients. Output: 50mW/cm2 light intensity. Benefits: provides light therapy for mild to moderate acne management.

Clinical Evidence

Usability study conducted with 40 participants (ages 11-61). Results demonstrated participants could correctly determine device suitability for their acne level and comprehended instructions, risks, and warnings.

Technological Characteristics

Hand-held LED device; 415nm wavelength; 50mW/cm2 output. Materials: Rigid ABS. Power: 9V AC/DC supply. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62471/62471-2 (radiation).

Indications for Use

Indicated for OTC treatment of mild to moderate acne in men and women.

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

• Quasar Blue Light Therapy System (K093963)
• Tanda Skincare (K080591)
• Silkn Blue (121435)

Submission Summary (Full Text)

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### K131461

Page 1 of 3

### JAN - 6 2014

# 510(k) Summary of Safety & Effectiveness

LED Intellectual Properties, LLC.

Device: LightStim for Acne Mini, Model: LS4AM

### 1. General Information

・・

Submitter: LED Intellectual Properties, LLC 16552 Von Karman Ave. Irvine. CA 92606

Contact Porson: Steve Marchese Office: [phone] Mobile: [phone]

Date Person: October 10, 2012

## 2. Names and Code

Device Name: LightStim for Acne Mini, model: L.S4AM

Classification Name: Laser Instrument, Surgical Powered -General and Plastic Surgery -Class 11, OLP

Although this device is not a laser and is intended for OTC use, the manufacturer thinks this is the closet applicable classification name.

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Page 2 of 3

### 3. Predicate Devices

.

Quasar Blue Light Therapy System (K093963), Tanda Skincare (K080591), Silkn Blue (121435)

## 4. Device Description

LightStim for Acne Mini, model: LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the uscr

## 5. Indications for Use / Intended Use

LightStim for Acne Mini, model: LS4AM is intended for Over-The-Counter use for the treatment of mild to moderate acne.

### 6. Performance Data

A usability study of this device was conducted with 40 participants. The participants ranged in age from 11 to 61. The results showed that the participants adequately decided whether or not to use the device for their level of acne, and showed that users comprehended risks, warnings, cautions, precautions, and proper use of the device, from the Instruction Manual.

Taking into consideration the table for substantial equivalence after an analysis of safety, indications, intended uses, performance, features, technological properties and methods of operations, LED Intellectual Properties, LLC believes that LightStim for Acne Mini has shown substantial equivalence to the predicate devices. Quasar Blue Light System (K093964), Tanda Skincare (K080591), Silkn Blue (121436).

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| Characteristic | Tanda Skincare<br>K080591 | Quasar Blue Light Therapy System<br>493963 | Silk'n Blue<br>121435 | LightStim for Acne Mini |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended Use | Mild to moderate acne. | Mild to moderate acne. | Mild to moderate acne. | Mild to moderate acne. |
| Indications for Use | There is no difference<br>between the subject and<br>the predicate device in<br>regards to indications for<br>use. | There is no difference<br>between the subject and<br>the predicate device in<br>regards to indications for<br>use. | There is no difference<br>between the subject<br>and the predicate<br>device in regards to<br>indications for use | LightStim for Acne Mini<br>is intended for the use<br>to treat mild to<br>moderate acne. |
| Target Population | Women and men with mild<br>to moderate acne. | Women and men with mild<br>to moderate acne. | Women and men with<br>mild to moderate acne. | Women and men with<br>mild to moderate acne. |
| Output in mW | 50mW/cm2 | 50mW/cm2 | 50mW/cm2 | 50mW/cm2 |
| Treatment Time | Treat breakout areas for 3<br>minutes, twice daily | 3 minutes per area | 3 to 4 minutes per area | 3 to 4 minutes per area |
| Treatment Area (cm2) | 27 | 10 | 7 | 15.5 |
| Wavelengths (nm) | 415 | 415 | 415 | 415 |
| Where Used | Home | Home | Home | Home |
| Design | Hand-held device | Hand-held device | Hand-held device | Hand-held device |
| Materials | Rigid ABS | Stainless Steel | Rigid ABS | Rigid ABS |
| Electromagnetic<br>Compatibility | 60601-1-2 | 60601-1-2 | 60601-1-2 | IEC 60601-1-2 |
| Basic safety and<br>essential performance | IEC 60601-1 | EC 60601-1 | IEC 60601-1 | EC 60601-1 |
| Radiation | Unknown | Unknown | Unknown | IEC 62471/IEC 62471-2 |

The conclusion drawn by LED Intellectual Properties. LLC. based on the comparison table and testing described above, is that the LightStim for Acne Mini raises no new issues of safety and is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an abstract symbol that resembles a person embracing another person.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 6, 2014

LED Intellectual Properties, LLC Mr. Steve Marchese CEO 16552 Von Karman Avenue Irvine, California 92606

Re: K131461

Trade/Device Name: LightStim for Acne Mini 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: OLP Dated: December 02, 2013 Received: December 03, 2013

#### Dear Mr. Marchese:

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. Steve Marchese, CEO

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.

Binita S. Ashar 2014.01.06 8-29 -05.00

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

510(K) Number (if known)

K131461

Devioe Name LightStim for Acne Mini

Indications for Use

LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.

Prescription Use_

Over-The-Counter Use -X-

(Per 21 CFR 801. 109)

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

OR

Conournence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogden -S
2014.01-03 15:49:51
-05'00"

(Division Sign-off) for BSA

Division of Surgical Devices

510(k) Number __K131461