(271 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use and basic device type.
Yes
The device is intended for the non-invasive treatment of periorbital wrinkles, which constitutes a therapeutic use.
No
The device is intended for non-invasive treatment of periorbital wrinkles, not for diagnosing any conditions.
No
The summary does not provide a device description, making it impossible to determine if it is software-only or includes hardware. The intended use describes a "device" for treatment, which often implies a physical component.
Based on the provided information, the FAQ™ 101 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the non-invasive treatment of periorbital wrinkles. This is a therapeutic or cosmetic purpose, not a diagnostic one.
- IVD Definition: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The FAQ™ 101 device does not involve the analysis of such specimens.
- Device Description (or lack thereof): While the description is "Not Found," the intended use clearly points away from diagnostic testing.
- Other Information: The other sections (image processing, AI, input imaging modality, anatomical site, patient age, user/setting) further support that this is a device applied externally to the body for treatment, not for analyzing internal samples.
Therefore, the FAQ™ 101 device falls outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.
Product codes (comma separated list FDA assigned to the subject device)
PAY, OHS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital
Indicated Patient Age Range
adult
Intended User / Care Setting
over-the-counter home use device
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.
(a)
Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.
(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.
(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.
(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Instructions for cleaning the device must be validated.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include:
(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.
(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.
(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Foreo, Inc. Danijela Domlijanovic Regulatory Compliance Specialist 1525 E. Pama Lane Las Vegas, Nevada 89119
April 5, 2023
Re: K222012 Trade/Device Name: Faq 101 Regulation Number: 21 CFR 878.4420 Regulation Name: Electrosurgical Device For Over-The-Counter Aesthetic Use Regulatory Class: Class II Product Code: PAY, OHS
Dear Danijela Domlijanovic:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 04/05/2023. Specifically, FDA is updating this SE Letter as an administrative correction to add the OHS product code to your device.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jianting Wang, OHT4: Office of Surgical and Infection Control Devices, Jianting.wang@fda.hhs.gov.
Sincerely,
Colin K. Chen -S
for
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
April 5, 2023
Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two main elements: a symbol on the left and the agency's name on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes around a staff. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in a clear, sans-serif font, with "FDA" in a larger, bolder font size than the rest of the text.
Foreo, Inc. Danijela Domlijanovic Regulatory Compliance Specialist 1525 E. Pama Lane Las Vegas, Nevada 89119
Re: K222012
Trade/Device Name: Faq 101 Regulation Number: 21 CFR 878.4420 Regulation Name: Electrosurgical Device For Over-The-Counter Aesthetic Use Regulatory Class: Class II Product Code: PAY Dated: June 6, 2022 Received: July 8, 2022
Dear Danijela Domlijanovic:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
2
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Colin K. Chen -S
for
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K222012
Device Name FAQ 101
Indications for Use (Describe)
FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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