(60 days)
No
The summary describes a TENS device for aesthetic use with different operational modes, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a "cosmetic device" intended for "over-the-counter aesthetic use," and its function, Transcutaneous Electrical Nerve Stimulation, is applied for "facial and neck stimulation or body skin stimulation."
No
The device is described as a "handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation" and a "cosmetic device." Its function is to deliver electrical impulses to stimulate skin, which falls under aesthetic or cosmetic purposes, not the diagnosis of a disease or condition.
No
The device description clearly states it is a handheld portable device with physical components like a rechargeable battery, charger, electrode metal pads, and attachments, indicating it is a hardware device, not software-only.
Based on the provided information, the BEAGANK 4T PLUS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation." This describes a device used on the body for cosmetic purposes, not for testing biological samples (like blood, urine, or tissue) outside of the body to diagnose or monitor a medical condition.
- Device Description: The description details a device that applies electrical impulses to the skin. This is consistent with a physical therapy or aesthetic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the BEAGANK 4T PLUS falls under the category of a physical or aesthetic device, not an IVD.
N/A
Intended Use / Indications for Use
The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
Product codes
NFO
Device Description
BEAGANK 4T PLUS is a cosmetic device which is intended for use on the face and body skin. The device contains a rechargeable lithium ion battery and is provided with a charger. The device has four electrode metal pads on the head that deliver electrical impulses to the face and body skin and provide four different operational modes.
The device operates by applying Transcutaneous Electrical Nerve Stimulation to the face and body skin. The electrodes that are positioned on the skin must be covered with a wet cotton pad. Purified water or commercially available cosmetic formulation liquid can be used as a conductive media to generate the electric pulses. Two attachments are provided with the BEAGANK 4T PLUS:
- Scalp attachment
- Small attachment
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial and neck skin or body skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Clinical Test Data: No new clinical studies have been submitted as part of this Premarket Notification.
Summary of Non-Clinical / Test Data: Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device. Testing confirmed that the device complies with safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1 and 60601-1-2. Testing confirmed that the device electrodes complies with safety standards for Biocompatibility testing, specifically ISO standards 10993-5, 10993-10, and 10993-23.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 21, 2023
Belega Inc. % Nana Nagashita Regulatory Consultant Ken Block Consulting Co., Ltd. 1-9-9 Tsukiji Chuo-ku, Tokyo 104-0045 Japan
Re: K233010
Trade/Device Name: Beagank 4T Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: September 15, 2023 Received: September 22, 2023
Dear Nana Nagashita:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known) K233010
Device Name BEAGANK 4T PLUS
Indications for Use (Describe)
The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY
| Owner/Submitter: | Belega Co., Ltd.
1-4-20 Sonezaki Shinchi, Kita-ku
Osaka-shi, Osaka, Japan 530-0002 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ken Block Consulting Co., Ltd.
Ms. Nana Nagashita
Regulatory consultant
1-9-9 Tsukiji, Chuo-ku
Tokyo, Japan 104-0045
TEL: +81-3-6260-6688
FAX: +81-3-6260-6689
nagashita@kenblockconsulting.com |
| Date Prepared: | September 20, 2023 |
| Submission Type: | Traditional 510(k) |
| Proposed Device | Manufacturer: BELEGA Co., Ltd.
Trade Name: BEAGANK 4T PLUS
Common Name: Aesthetic TENS Device
Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief
Product Code: NFO
Regulatory Standard: 21 CFR 882.5890 |
| Predicate Device: | 510(k) Number: K191951
Manufacturer: Avazzia, Inc.
Trade Name: Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI LIFT Device
Common Name: Aesthetic TENS Device
Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief
Product Code: NFO
Regulatory Standard: 21 CFR 882.5890 |
| Reference Device: | 510(k) Number: K011935
Manufacturer: Salton Inc.
Trade Name: Rejuvenique® system, Model RJV-10
Common Name: Aesthetic TENS Device
Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief
Product Code: NFO, GYB (Media, Conductive)
Regulatory Standard: 21 CFR 882.5890, 21 CFR 882.1275 (Media, Conductive) |
| Reference Device: | 510(k) Number: K181008
Manufacturer: Carol Cole Company dba NuFACE
Trade Name: NuFACE Trinity
Common Name: Aesthetic TENS Device
Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief
Product Code: NFO |
5
BEAGANK 4T PLUS is a cosmetic device which is intended for use on the face and body Device Description: skin. The device contains a rechargeable lithium ion battery and is provided with a charger. The device has four electrode metal pads on the head that deliver electrical impulses to the face and body skin and provide four different operational modes.
The device operates by applying Transcutaneous Electrical Nerve Stimulation to the face and body skin. The electrodes that are positioned on the skin must be covered with a wet cotton pad. Purified water or commercially available cosmetic formulation liquid can be used as a conductive media to generate the electric pulses. Two attachments are provided with the BEAGANK 4T PLUS:
- Scalp attachment -
- Small attachment
Statement of The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic Intended Use: use including facial and neck stimulation or body skin stimulation.
Summary of The major differences between the proposed and predicate devices are summarized in the Technological tables below: Characteristics:
| Table 1: Basic characteristics | |||||
|---|---|---|---|---|---|
| New Device | Predicate Device | Reference Device | Reference Device | ||
| Trade Name | BEAGANK 4T | ||||
| PLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity | ||
| 510(k) | K233010 | K191951 | K011935 | K181008 | |
| Indication for Use | The BEAGANK | ||||
| 4T PLUS is a | |||||
| handheld portable | |||||
| device for over- | |||||
| the-counter | |||||
| aesthetic use | |||||
| including facial | |||||
| and neck | |||||
| stimulation or | |||||
| body skin | |||||
| stimulation. | The Avazzia OTC | ||||
| TENS for | |||||
| aesthetics, model | |||||
| BEST-AV1™: | |||||
| EZZI-LIFT™ | |||||
| Device is indicated | |||||
| for over-the- | |||||
| counter aesthetic | |||||
| use including | |||||
| facial and neck | |||||
| stimulation or | |||||
| body skin | |||||
| stimulation. | Rejuvenique | ||||
| system is indicated | |||||
| for cosmetic use. | The NuFACE | ||||
| Trinity is intended | |||||
| for facial and neck | |||||
| stimulation and is | |||||
| indicated for over- | |||||
| the-counter | |||||
| cosmetic use. | |||||
| Device Class | Class II | Class II | Class II | Class II | |
| Operating Power | Internal | ||||
| rechargeable | |||||
| Lithium-ion | |||||
| battery | Two 1.5 V AA | ||||
| batteries | 9 V battery | Internal | |||
| rechargeable | |||||
| Lithium-ion | |||||
| battery | |||||
| Method of Line Current | |||||
| Isolation | Type BF | Unknown | Unknown | Type BF | |
| Patient | |||||
| Leakage | |||||
| Current | Normal | DC: Testing confirmed that the device electrodes complies with safety standards for Biocompatibility testing, specifically ISO standards 10993-5, 10993-10, and 10993-23. |
Company considers the BEAGANK 4T PLUS device to be substantially equivalent to the Conclusion: predicate device and reference devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.