VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
Device Facts
| Record ID | K260179 |
|---|---|
| Device Name | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) |
| Applicant | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. |
| Product Code | NFO · Neurology |
| Decision Date | Jun 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device. Micro-current function: The micro current stimulation mode is intended for facial stimulation and is indicated for over-the counter cosmetic use.
Device Story
Hand-held device; consists of host, removable treatment head with stainless steel bristles, and charging cable. Device generates micro-currents via stainless steel bristles applied to facial skin. User operates via button for power and mode switching; device features automatic 10-minute shut-off. Powered by internal rechargeable lithium battery. Output is transcutaneous micro-current electrical stimulation for aesthetic purposes. Healthcare provider does not operate; intended for patient self-use in home environment. Output provides cosmetic facial stimulation; intended to mimic effects of predicate aesthetic stimulators.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-5, -10, -23), electrical safety (IEC 60601-1, -1-11, -2-10), EMC (IEC 60601-1-2), and battery safety (IEC 62133-2). Software verification and validation confirmed mitigation of hazards to acceptable levels.
Technological Characteristics
Hand-held, battery-powered stimulator. Enclosure: ABS; Bristles: Stainless steel. Output: Monophasic pulsed micro-current (1.6kHz). Safety: Type BF protection. Biocompatibility: ISO 10993 compliant. Connectivity: None. Sterilization: Not applicable. Software: Microprocessor-controlled with 10-minute timer.
Indications for Use
Indicated for over-the-counter cosmetic facial stimulation in adult users.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 3, 2026
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
% Bing Huang
RA Engineer
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90
Qianhai Rd.
Shenzhen, Guangdong 518052
China
Re: K260179
Trade/Device Name: VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
Regulatory Class: Class II
Product Code: NFO
Dated: May 8, 2026
Received: May 8, 2026
Dear Bing Huang:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.gov
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K260179 - Bing Huang
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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assistance/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,
Tushar Bansal -S
Tushar Bansal, PhD
Acting Assistant Director, Acute Injury Devices Team
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260179 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | | |
| Please provide your Indications for Use below. | | ? |
| VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device. Micro-current function: The micro current stimulation mode is intended for facial stimulation and is indicated for over-the counter cosmetic use. | | |
| Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary---
# 510(k) Summary
**Date: 2026-06-03**
### I. Submitter
TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD. 29/F, Block B, Tiley Central Plaza, No.195 Haide 3rd Road, Nanshan District, Shenzhen, China.
Post code: 518064
Tel.: +86 400-1191-180
Zhou Elin
Title: CEO
Tel.: +86 755 3366 2222 ext.666
Email: chow@touchbeauty.com
### II. Device
Name of Device: VITA Multi-Function Head Brush
Model(s): TB-2343F, TB-2442F
Common or Usual Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Classification Name: Transcutaneous electrical nerve stimulator for pain relief
Regulatory Class: II
Product Code: NFO
Regulation Number: 21CRF 882.5890
**Note:** The device function-under-review in this 510(k) is transcutaneous microcurrent electrical stimulation for aesthetic purposes, which falls under the NFO product code under the regulation 21 CRF 882.5890. Only this specific device function was cleared in this 510(k).
### III. Predicate Device
| Manufacturer | Predicate Device | 510(k) Number | Cleared Date |
| --- | --- | --- | --- |
| XTREEM PULSE LLC | PureLift Pro Plus | K221443 | October 21, 2022 |
| BELEGA Co., Ltd. | Beagank 4T Plus | K233010 | November 21, 2023 |
| Carol Cole Company | NuFACE Mini Device | K133823 | Apr 17, 2014 |
### IV. Device Description
The VITA Multi-Function Head Brush is a hand-held device. It consists of a host, a removable treatment head, and a charging cable. The host has a button, indicator lights, and the device's power-
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary---
on/off, treatment mode switch can be achieved by pressing the button. The removable treatment head has lights row, stainless steel bristles.
The device generates a micro-currents on the stainless steel bristles which will applied on the facial skin for facial stimulation.
The device will automatically shut down after each mode completes treatment within 10 minutes. The device is powered by a built-in rechargeable lithium battery.
## V. Indications for Use
VITA Multi-Function Head Brush is an Over-The-Counter (OTC) device.
Micro-current function: The micro current stimulation mode is intended for facial stimulation and is indicated for over-the counter cosmetic use.
## VI. Comparison of Technological Characteristics With the Predicate Device
VITA Multi-Function Head Brush is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary---
| **Comparison Elements** | **Subject Device** | **Primary Predicate Device** | **Predicate Device 2** | **Predicate Device 3** | **Remark** |
| --- | --- | --- | --- | --- | --- |
| 510(k) Number | Pending | K221443 | K233010 | K133823 | / |
| Trade name | VITA Multi-Function Head Brush (Model(s): TB-2343F, TB-2442F) | PureLift Pro Plus | Beagank 4T Plus | NuFACE Mini Device | / |
| Manufacturer | TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD | XTREEM PULSE LLC | BELEGA Co., Ltd. | Carol Cole Company | / |
| Regulation number | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | Same |
| Product code | NFO | NFO | NFO | NFO | Same |
| Device classification | II | II | II | II | Same |
| Prescription or OTC | OTC | OTC | OTC | OTC | Same |
| Indication for use/ Intended use | VITA Multi-Function Head Brush is an Over-the-Counter (OTC) device. Face Mode: Micro-current function: The micro current stimulation mode is intended for facial stimulation and is indicated for over-the counter cosmetic use. | Intended for facial stimulation and indicated for over-the-counter cosmetic 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 NuFACE Mini Facial Toning device is intended for facial stimulation and is indicated oor over-the-counter cosmetic use (21 CFR 807 Subpart C). | Same |
| Handheld or stationary | Hand-held Type | Hand-held Type | Hand-held Type | Hand-held Type | Same |
| Treatment area | Face | Face | Face and neck or body | Face | Same |
| Number of out channels | 1 output channel | 1 output channel | 1 | 1 | Same |
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary---
| **Comparison Elements** | **Subject Device** | **Primary Predicate Device** | **Predicate Device 2** | **Predicate Device 3** | **Remark** |
| --- | --- | --- | --- | --- | --- |
| Regulated current or regulated voltage | Voltage | Regulated current | Voltage | Both | Same |
| Software/ Firmware/ Microprocessor Control | Yes | Yes | Yes | Yes | Same |
| Indicator Display | Yes | Yes | Unknown | Yes | Same |
| Timer range | 10 minutes a time | 10 minutes only | Maximum 5 minutes | 21 minutes | Same as the primary |
| Type of protection | Type BF | Type BF | Type BF | Unknown | Same |
| On/off status | Yes | Yes | Yes | Yes | Same |
| Waveform | Pulses Monophasic | Pulses Monophasic, alternating polarity | Rectangle, biphasic asymmetric | Pulsed Monophasic | Same The waveform of subject device is the same as predicate device 3. |
| Shape | Rectangular Pulses | Rectangular Pulses | Rectangle, biphasic asymmetric | Modulated Square | Same |
| Maximum output voltage | 20Vpp @500Ω 32Vpp @ 2kΩ 44Vpp @ 10kΩ | 20Vpp(@500Ω) 32Vpp(@2kΩ) 44Vpp(@10kΩ) | Mode 1: 127mV (0.12V)@500Ω 515mV (0.51V)@2KΩ 1.83V@10KΩ | Specify units: 222mV @500Ω 781mV @ 2kΩ 3.90V @ 10kΩ | Same |
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary---
| Comparison Elements | Subject Device | Primary Predicate Device | Predicate Device 2 | Predicate Device 3 | Remark |
| --- | --- | --- | --- | --- | --- |
| | | | Mode 2: 110mV(0.11V)@500Ω 507mV(0.50V)@2KΩ 1.87V@10KΩ Mode 3: 16.6V@500Ω 21.0V@2KΩ 22.5V@10KΩ Mode 4: 15.3V@500Ω 21.2V@2KΩ 22.9V@10KΩ | | |
| Maximum output current | 2.96mA_{r.m.s} @500Ω 1.35mA_{r.m.s} @ 2kΩ 0.515mA_{r.m.s}@10kΩ | 9mA(@500Ω) 4.4mA(@2kΩ) 1.2mA(@10kΩ) | Mode 1: 0.19mA@500Ω 0.18mA@2KΩ 0.16mA@10KΩ Mode 2: 0.45mA@500Ω 0.39mA@2KΩ 0.24mA@10KΩ Mode 3: | 396μA @500Ω 395μA@ 2kΩ 391μA@ 10kΩ | Similar Note 1 |
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary---
| Comparison Elements | Subject Device | Primary Predicate Device | Predicate Device 2 | Predicate Device 3 | Remark |
| --- | --- | --- | --- | --- | --- |
| | | | 30.8mA@500Ω 8.52mA@2KΩ 2.26mA@10KΩ Mode 4: 31.4mA@500Ω 8.60mA@2KΩ 2.15mA@10KΩ | | |
| Pulse width | 4μs | 4μs | Mode 1: 130μs Mode 2: 130μs Mode 3: 80μs Mode 4: 92μs | Specify unites ON Phase: 60.4ms OFF phase: 60.4ms Total Pulse Width: 120.8ms | Same |
| Frequency (Hz) | 1.6kHz | 1.37kHz ~ 1.73kHz | Mode 1: 3.80kHz Mode 2: 3.80kHz Mode 3: 3.65kHz Mode 4: 1.64kHz | 8.28Hz | **Similar Note 2** |
| Symmetrical phases | Not multiphasic | Not multiphasic | No | Not Multiphasic | Same |
| Net charge (μC per pulse train) | 0.16μC | 0μC per pulse train | Mode 1: 0.025μC@500Ω Mode 2: 0.025μC@500Ω Mode 3: -1.3μC@500Ω Mode 4: 0μC@500Ω | 1.43μC | **Different Note 3** |
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary---
| Comparison Elements | Subject Device | Primary Predicate Device | Predicate Device 2 | Predicate Device 3 | Remark |
| --- | --- | --- | --- | --- | --- |
| Maximum phase charge (μC) | 0.2304μC | 5.81μC@500Ω | Mode1: 0.059μC@500Ω Mode 2: 0.025μC@500Ω Mode 3: 2.2μC@500Ω Mode 4: 0.29μC@500Ω | 23.7μC | Different Note 3 |
| Maximum current density (mA/cm²) | 1.62mA/cm² | 8.8mA/cm²@500Ω | With a wet cotton pad (Purified water) Mode 1: 0.15~1.36mA/cm²@500Ω Mode 2: 0.10~0.92mA/cm²@500Ω Mode 3: 4.26~38.43mA/cm²@500Ω Mode 4: 3.13~28.21mA/cm²@500Ω | 0.514mA/cm² | Similar Note 4 |
| Maximum power density | 2394μW/cm² | 39600μW/cm² | With a wet cotton pad: Mode 1: 11.39μW/cm²@500Ω Mode 2: 33.87μW/cm²@500Ω Mode 3: 1124.0μW/cm²@500Ω Mode 4: 556.96μW/cm²@500Ω | 1981μW/cm² | Different Note 4 |
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary---
| Comparison Elements | Subject Device | Primary Predicate Device | Predicate Device 2 | Predicate Device 3 | Remark |
| --- | --- | --- | --- | --- | --- |
| Main Materials | Enclosure: ABS; Stainless Steel Bristles Button: Stainless; | Not publicly available | ABS | Thermo Plastic | Different, but solved by biocompatibility tests |
| Electrical safety | IEC 60601-1 IEC 60601-1-11 IEC 60601-1-2 IEC 60601-2-10 IEC 62133-2 | ANSI/AAMI ES60601-1 IEC 60601-1-2 IEC 60601-2-10 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-2 | IEC 60601-1 IEC 60601-1-2 | Same |
| Biocompatibility feature | All patient contacting materials are complied with ISO 10993-5, ISO 10993-10 and ISO 10993-23 | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 ISO 10993-23 | Not publicly available | Same |
# Note 1:
The maximum output voltage of the subject device is same as the primary predicate device(K221443). The maximum output current seems to be different from the predicate devices, but it is within the range of the predicate devices. Besides, the device has been tested for electrical safety as per IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 requirements, so this difference does not impact its safety and effectiveness.
# Note 2:
Though the Frequency of the subject device is a little different from the primary predicate device, it is within the rang of the primary predicate device. So this difference will not raise any safety or effectiveness issues.
# Note 3:
Though Maximum phase charge of the subject device is a little different from the primary predicate device, it is within the rang of the primary predicate device and secondary predicate device. So this difference will not raise any safety or effectiveness issues.
The waveform of the subject device is the same as the predicate device 3, both are Pulsed Monophasic. And the net charge (0.16µC) of the subject device, which is much lower than the requirement in clause 8.4.3 of IEC 60601-1 that the shored charge should not exceed 45µC, is much smaller than that of the predicate device 3 (1.43µC), as well as that of the mode 3 of the predicate device 2 (-1.3µC). Besides, the subject device has been tested for electrical safety as per IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 requirements, so this difference does not impact its safety and
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary---
effectiveness. Therefore, the waveform and net charge of the subject device will not increase the risk of charge accumulation at the electrode-skin interface.
# Note 4:
Though the Maximum current density and Maximum power density of the subject device is a little different from the primary predicate device, it is within the range of the primary predicate device and secondary predicate device, and the 1.62mA/cm² is less than the limit of 2mA/cm² specified in IEC 60601-2-10. The subject device has provided adequate electrical safety and performance testings, which were conducted according to applicable standards for nerve and muscle stimulators (including IEC 60601-1 and IEC 60601-2-10) as well as lab bench performance evaluation. So this difference will not raise any safety or effectiveness issues.
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary
## VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
### 1) Biocompatibility Safety
The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation in accordance with the “Use of International Standard ISO 10993-1, ‘Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020’”, as recommended by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5: 2009, Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23: 2021, Biological evaluation of medical devices - Part 23: Tests for irritation
### 2) Electrical Safety and EMC Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
- IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility
- IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and Essential Performance –Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
### 3) Software Verification and Validation
Software documentation consistent with *Basic Documentation* of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
### Summary
Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate devices.
## VIII. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, it can be concluded that the
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TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD.
510(k)s –510(k) Summary
VITA Multi-Function Head Brush is as safe, as effective, and performs as well as the legally marketed predicate devices.
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