(86 days)
The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Ultra Facial Toning System." It is a regulatory document addressing the substantial equivalence of the device to existing predicate devices. It does not contain any information about acceptance criteria or the study that proves the device meets those criteria.
Specifically, the document:
- Confirms K181062 as the premarket notification number.
- States the Trade/Device Name: Ultra Facial Toning System.
- Identifies the Regulation Number and Name for Transcutaneous Electrical Nerve Stimulator For Pain Relief.
- Classifies the device as Class II with Product Code NFO.
- Declares the device substantially equivalent for its stated indications for use.
- Outlines general controls provisions and other regulatory requirements.
- Provides contact information for various FDA departments.
- Details the "Indications for Use" which states: "The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use."
- Notes it is a Prescription Use device.
Therefore, it is not possible to describe acceptance criteria or a study proving the device meets them based on the provided text, as this information is not present in the document.
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July 18, 2018
Micro Current Technology, Inc. David Suzuki Official Correspondent 2244 1st Avenue South Seattle, Washington 98134
Re: K181062
Trade/Device Name: Ultra Facial Toning System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: April 18, 2018 Received: April 23, 2018
Dear Mr. Suzuki:
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 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 of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Michael J. Hoffmann -S
Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181062
Device Name Ultra Facial Toning System
Indications for Use (Describe)
The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).