(293 days)
Not Found
No
The device description and performance studies focus on controlled heat delivery and usability, with no mention of AI or ML.
Yes
The device is indicated for the "treatment" of individual acne pimples, which directly implies a therapeutic action.
No
The device is indicated for the "treatment of individual acne pimples" and is described as producing heat for "treating mild to moderate acne." There is no mention of it being used to identify, detect, or diagnose any medical condition.
No
The device description explicitly states that the CLEANE and CLEANE POP are "potable had-held devices" with a "treatment tip" made from a "biocompatible material," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of individual acne pimples." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device applies "low level sustained heat" to treat acne. This is a physical treatment method, not a method for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting biomarkers, pathogens, or any other indicators of disease.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any of these functions.
N/A
Intended Use / Indications for Use
CLEANE and CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Product codes
OZC
Device 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 a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 890.5740 Powered heating pad.
(a)
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.(b)
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.
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111/34/
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
-
- Company making the submission
| Submitter | |
|---|---|
| Name | MEDICON Co., Ltd. |
| Address | 1642-5 Donghwa-Ri, Munmak-Eup, Gangwon T.P 204-205 |
| Wonju-Si, Gangwon-Do, South Korea | |
| Phone | +82-33-743-1291 |
| Fax | +82-33-743-1287 |
-
- U.S Agent/Contact Person
LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Phone: 714-869-3080 Fax: 714-409-3357 Email: info@LKconsultinggroup.com
- U.S Agent/Contact Person
- Device
Trade Name: CLEANE / CLEANE POP Common Name: Acne Treatment Device Classification: Class II Classification regulation: 21 CFR890.5740 Product Code: OZC
-
- Predicate Device:
Zeno by Tyrell, Inc. (K043377)
- Predicate Device:
- 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
1
a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish.
- Indication for use:
CLEANE and CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
- 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.
- 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
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111341