CLEANE / CLEANE POP

K111341 · Medicon Co., Ltd. · OZC · Feb 29, 2012 · Physical Medicine

Device Facts

• Record ID: K111341
• Device Name: CLEANE / CLEANE POP
• Applicant: Medicon Co., Ltd.
• Product Code: OZC · Physical Medicine
• Decision Date: Feb 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CLEANE and CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Device Story

CLEANE and CLEANE POP are portable, hand-held devices for treatment of individual acne blemishes. Devices deliver controlled, low-level sustained heat to individual pimples for 2.5 minutes at a preset temperature. Intended for over-the-counter use by lay users. Treatment tip composed of biocompatible material. Device operation involves applying the heated tip directly to the blemish. Heat application intended to treat inflammatory acne. Usability validated via self-selection and labeling comprehension studies.

Clinical Evidence

No clinical efficacy trials performed. Evidence consists of bench testing and human factors studies. Biocompatibility of tip material confirmed per ISO 10993. EMI testing performed per IEC 60601. Usability validated through self-selection and labeling comprehension studies, demonstrating that lay users could correctly identify appropriate use and operate the device without assistance.

Technological Characteristics

Hand-held, portable device. Treatment tip made of biocompatible material. Operates via controlled low-level heat delivery. Powered heating pad (21 CFR 890.5740). Tested for EMI per IEC 60601. No software or algorithm described.

Indications for Use

Indicated for treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Regulatory Classification

Identification

A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

Predicate Devices

• Zeno by Tyrell, Inc. (K043377)

Submission Summary (Full Text)

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## 510(k) Summary

FEB 2 9 2012

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: __ 02/28/2012

- 1. Company making the submission

| | Submitter |
|---------|-----------------------------------------------------------------------------------------|
| Name | MEDICON Co., Ltd. |
| Address | 1642-5 Donghwa-Ri, Munmak-Eup, Gangwon T.P 204-205<br>Wonju-Si, Gangwon-Do, South Korea |
| Phone | [phone] |
| Fax | [phone] |

- 2. U.S Agent/Contact Person
LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Phone: [phone] Fax: [phone] Email: [e-mail]

3. Device

Trade Name: CLEANE / CLEANE POP Common Name: Acne Treatment Device Classification: Class II Classification regulation: 21 CFR890.5740 Product Code: OZC

- 4. Predicate Device:
Zeno by Tyrell, Inc. (K043377)

5. Description:

The CLEANE and the CLEANE POP are potable had-held devices that produce accurately controlled low level sustained heat for use in treating mild to moderate acne. The devices are designed to treat individual acne blemishes for 2 1/2 minutes at

510(k) Submission.

510(k) summary , 1 / 2 page

P. 1 Az

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a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish.

6. Indication for use:

CLEANE and CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

7. Performance Data

Biocompatibility testing of the tip material was conducted in accordance with ISO 10993 Biological Testing of Medical and the tip material is considered biocompatible.

CLEANE and CLEANE POP were tested for EM1 in accordance with the IEC 60601. They operate within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601 standard.

Self selection study and labeling comprehension study were conducted to ensure usability of lay users. The performance data supplied in this 510K demonstrated that the majority of study participants were able to properly self-select themselves using the box labeling and were able to properly use the device by reading the instructions for use without any assistance.

8. Basis for Substantial Equivalence

Upon reviewing the safety and effectiveness information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the CLEANE and the CLEANE POP are determined by Medicon Co., Ltd. to be substantially equivalent to the predicate device.

510(k) Submission.

. P, 2/2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

FEB 2 9 2012

Medicon Co., Ltd. % LK Consulting Group Ms. Priscilla Chung 951 Starbuck Street, Unit J Fullerton, California 92833

Re: K111341

Trade/Device Name: CLEANE / CLEANE POP Regulation Number: 21 CFR 890.5740 Regulation Name: Powered heating pad Regulatory Class: Class II Product Code: OZC Dated: February 01, 2012 Received: February 06, 2012

Dear Ms. Chung:

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

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Page 2 -- Ms. Priscilla Chung

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Malkerson

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 (if known): _ k | | | 3 4 | ____________________________________________________________________________________________________________________________________

CLEANE / CLEANE POP Device Name:

## Indications for Use:

The CLEANE and the CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use V (21 CFR 807 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111341