Who is the manufacturer of Micro-current facial cold and hot service (model: TPML-100)?

Li-Tek Electronics Technology C0., Ltd. filed the 510(k) submission for Micro-current facial cold and hot service (model: TPML-100) (K213039).

What is the FDA product code for Micro-current facial cold and hot service (model: TPML-100)?

OLP. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Micro-current facial cold and hot service (model: TPML-100)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Micro-current facial cold and hot service (model: TPML-100)?

LED Light Therapy Device, Model: KN-7000C (K180900); Trinity ELE Plus Facial Toning Device (K201906); Smart Photon Micro-current Device, Model: EP-300 (K162652).

Who can help prepare an FDA 510(k) submission like Micro-current facial cold and hot service (model: TPML-100)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Micro-current facial cold and hot service (model: TPML-100)

K213039 · Li-Tek Electronics Technology C0., Ltd. · OLP · May 25, 2022 · General, Plastic Surgery

Device Facts

Record ID	K213039
Device Name	Micro-current facial cold and hot service (model: TPML-100)
Applicant	Li-Tek Electronics Technology C0., Ltd.
Product Code	OLP · General, Plastic Surgery
Decision Date	May 25, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use.

Device Story

Hand-held, reusable device for home aesthetic use; powered by internal rechargeable lithium battery. Features three metal heads for micro-current (EMS) facial stimulation and warming/cooling, plus two LED windows (red 630nm, blue 415nm) for acne treatment. Includes micro-motor for vibration. User applies device to facial skin; selects modes for EMS, LED irradiation, vibration, or thermal therapy. EMS function delivers low-frequency micro-current to facial skin; LED function provides narrow spectral bandwidth light. Device output is user-adjustable. Intended to provide facial stimulation and treat inflammatory acne; benefits include aesthetic skin improvement and acne management.

Clinical Evidence

No clinical data. Safety and performance demonstrated via lab bench testing, including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-2-57, and ISO 10993-5/10 biocompatibility testing. Usability testing confirmed lay user ability to self-select, operate safely, and understand labeling.

Technological Characteristics

Materials: PC, ABS, Stainless steel (SUS 304). Energy: Internal rechargeable lithium-ion battery (3.7V). Output: Bi-phase square-wave pulse (57Hz). Dimensions: 188x50x55mm. Connectivity: USB charging. Sterilization: Non-sterile. Standards: IEC 60601 series, ISO 10993.

Indications for Use

Indicated for treatment of mild to moderate inflammatory acne and facial stimulation for over-the-counter aesthetic use in the home environment.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

LED Light Therapy Device, Model: KN-7000C (K180900)
Trinity ELE Plus Facial Toning Device (K201906)
Smart Photon Micro-current Device, Model: EP-300 (K162652)

Reference Devices

Avazzia OTC TENS for aesthetics, Model: BEST-AV1: EZZI-LIFT Device (K191951)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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. May 25, 2022 Li-Tek Electronics Technology C0., Ltd % Jet Li Regulation manager Guangdong Jianda Medical Technology Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China Re: K213039 Trade/Device Name: Micro-current facial cold and hot service (model: TPML-100) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OLP, NFO Dated: March 29, 2022 Received: April 15, 2022 Dear Jet Li: 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. {1}------------------------------------------------ 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 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 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. Purva Pandya 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K213039 #### Device Name Micro-current vibration facial cold and hot service (model: TPML-100) Indications for Use (Describe) Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for over the counter aesthetic use. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Date of the summary prepared: May 24, 2022 # 510(k) Summary ## K213039 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. This is a Traditional 510(K) submission, and there were no prior submissions for the subject device. ### 1. Submitter's Information #### Sponsor - � Company Name: Li-Tek Electronics Technology Co., Ltd. - Address: No. 8~13, the industrial park of Jinshagang, Shixia village, Dalang town, � Dongguan city, Guangdong, China - � Phone: + 86-769-83117755 - � Email: quality5@li-tek.com - Contact Person (including title): Barry Yuan (Quality Director) � ### Application Correspondent: - � Guangdong Jianda Medical Technology Co., Ltd. - � Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China - � Contact Person: Mr. Jett Lee - Title: Regulation Manager � - � Tel: +86-13512755282 - � Email: jianda-lee@foxmail.com ### 2. Subject Device Information - � 510(k) number: K213039 - � Type of 510(k) submission: Traditional - Classification: Over-The-Counter Powered Light Based Laser For Acne; � {4}------------------------------------------------ Transcutaneous electrical nerve stimulator for pain relief - Trade Name: Micro-current vibration facial cold and hot service � - Model: TPML-100 � - Review Panel: General& Plastic Surgery / Neurology � - � Product Code: OLP / NFO - � Regulation Number: 21 CFR 878.4810 / 882.5890 - � Requlation Class: 2 ### 3. Predicate Device Information #### Primary Predicate Device I - 510(k) number: K180900 � - � Sponsor: UVBIOTEK, LLC - � Classification: Over-The-Counter Powered Light Based Laser For Acne - � Trade Name: LED Light Therapy Device, Model: KN-7000C - � Review Panel: General & Plastic Surgery - � Product Code: OLP - Regulation Number: 21 CFR 878.4810 � - Regulation Class: 2 � ### Secondary Predicate Device II - 510(k) number: K201906 � - � Sponsor: LG Electronics, Inc. - � Classification: Transcutaneous electrical nerve stimulator for pain relief - � Trade Name: Trinity ELE Plus Facial Toning Device - � Model: Trinity ELE Plus - � Review Panel: Neurology - Product Code: NFO � - Regulation Number: 21 CFR 882.5890 � - � Regulation Class: 2 {5}------------------------------------------------ ### Predicate Device III - 510(k) number: K162652 � - � Sponsor: Li-tek Electronic Technology Corporation. - Classification: Transcutaneous electrical nerve stimulator for pain relief � - � Trade Name: Smart Photon Micro-current Device - � Model: EP-300 - � Review Panel: Neurology - Product Code: NFO � - � Regulation Number: 21 CFR 882.5890 - � Regulation Class: 2 ### Reference Device - � 510(k) number: K191951 - � Sponsor: Avazzia, Inc. - � Classification: Transcutaneous electrical nerve stimulator for pain relief - � Trade Name: Avazzia OTC TENS for aesthetics - Model: BEST-AV1TM: EZZI-LIFTT™ Device � - Review Panel: Neurology � - � Product Code: NFO - � Regulation Number: 21 CFR 882.5890 - � Regulation Class: 2 ### 4. Device Description The Micro-current vibration facial cold and hot service device (Model: TPML-100) is a hand-held, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, and USB cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the USB cable. The device is un-usable when charging. {6}------------------------------------------------ The device is only home environment use, which has three metal heads (Dual / Single), and two LED light windows (Red / Blue) to provides following functions: - a) EMS (micro current output stimulation) function. The device generates a low-frequency micro-current on the Dual Heads which will applied in the facial skin to do facial stimulation. - b) Red and Blue LED irradiation function. The device outputs the red light at the wavelength of 630 ± 10 nm and the blue light at the wavelength of 415 ± 10 nm to apply the light in narrow spectral bandwidth on facial skin to treat mild to moderate acne. - c) Vibration function. The device generates different patterns of micro-vibration by a builtin micro motor to relax the facial skin. (This function is classified as class I and not need for 510K.) - d) Warming and Cooling function. The device heats Dual Heads up to 44 ± 2 °C or cool the Single Head down to 10 ± 2 °C, to relax the facial skin with a warm or cold sensation. (This function is not for medical purpose.) ## 5. Intended Use / Indications for Use Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use. ## 6. Test Summary Micro-current vibration facial cold and hot service has been evaluated for its safety and performance by lab bench testing as following: - � IEC 60601-1:2012 , Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - � IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility {7}------------------------------------------------ - � IEC 60601-1-11:2015 Medical electrical equipment - part 1-11: 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 60601-2-10:2012 AMD1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators - � IEC 60601-2-57:2011 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use - � ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity - � ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization ## 7. Comparison to predicate device and conclusion The technological characteristics, features, specifications, materials, and intended use of Micro-current facial cold and hot service is substantially equivalent to the predicate devices quoted above. Even there is minor difference on output waveform parameters and construction between subject device and predicate device. But the differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. {8}------------------------------------------------ Micro-current vibration facial cold and hot service, Model: TPML-100 Subject Device: | Device | Proposed Device | Predicate Device I | Predicate Device II | Predicate Device III | Reference Device | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Primary | Secondary | Secondary | | | 510(K) | K213039 | K180900 | K201906 | K162652 | K191951 | | Manufacturer | Li-Tek Electronics Technology Co., Ltd | Uvbiotek, LLC | Carol Cole Company dba NūFACE | Li-Tek Electronics Technology Co., Ltd | Avazzia, Inc | | Product Name | Micro-current vibration facial cold and hot service TPML-100 | LED Light Therapy Device KN-7000C | Trinity ELE Plus Facial Toning Device Trinity ELE Plus | Smart Photon Micro- current Device EP-300 | Avazzia OTC TENS for Aesthetics BEST-AV1 EZZI-LIFT Device | | Classification | Class II, OLP / NFO 21 CFR878.4810/882.5890 | Class II, OLP 21 CFR878.4810 | Class II, NFO 21 CFR 882.5890 | Class II, NFO/OHS/OLP 21 CFR 882.5890 | Class II, NFO 21 CFR 882.5890 | | Prescription/ OTC | OTC | OTC | OTC | OTC | OTC | | Intended Use | Micro-current facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use. | LED Light Therapy Device is indicated for the treatment of mild to moderate inflammatory acne. | The Trinity ELE Plus and Trinity ELE Plus Pro are intended for facial stimulation and are indicated for over the counter cosmetic use. | For micro current Stimulation mode: The device is intended for Facial stimulation and is indicated for over-the counter aesthetic use. | The Avazzia OTC TENS for aesthetics, model BEST-AV1TM: EZZI- LIFTTM Device is indicated for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation. | | Power Supply | Charger (not included) input: DC 5V, 1A | Adapter Input: 100-240V a.c. 50/60Hz, 0.5A max. | Unknown | 3.7V, 800mAh rechargeable lithium battery | 3V | | | Internal battery: 3.7Vd.c. 900mAh | Adapter Output: 5V d.c. 2A Main unit input: 5V d.c. 2A/ Internal battery: 3.6Vd.c. 2200mAh | | | | | Battery | Lithium-ion | Lithium-ion | Lithium-ion | Lithium-ion | 2* 1.5 V AA batteries | | Software Control | YES | YES | YES | YES | YES | | Handheld | YES | YES | YES | YES | YES | | Effective irradiance | Blue light: 25 mw/cm² ±10% Red light: 45 mw/cm²±10% | Blue light: 25±5 mw/cm² Red light: 45±5 mw/cm² | / | / | / | | LED Amount | 6 red LEDs 4 blue LEDs | 48 red LEDs 48 blue LEDs | / | / | / | | Wavelength | Blue light: 415±10 nm Red light: 630±10 nm | Blue light: 417±10 nm Red light: 633±10 nm | / | / | / | | Energy Output | User adjustable for EMS | / | User adjustable, variable output frequency, microcurrent continuously alternates and delivered via dual chrome-plated precise wands | User adjustable for EMS | / | | Special Requirements | No | No | Requires Conductive Gel | Requires Conductive Gel | No | {9}------------------------------------------------ Micro-current vibration facial cold and hot service, Model: TPML-100 Subject Device: {10}------------------------------------------------ Micro-current vibration facial cold and hot service, Model: TPML-100 Subject Device: | Waveform | Bi-phase square-wave | / | Pulsed Biphasic, Modulated Square | Bi-phase square-wave | positive square wave followed by a damped sinusoidal waveformof | |-------------------------------|---------------------------------------------------------------|---|------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------| | Type | pulse | / | | pulse | variable duration depending on damping and body loading | | Maximum | 225 mV @500Ω, ±10% | | 170 mV @500Ω, ±10% | 1.49V @ 500Ω | -42V @ 500Ω | | Output | 900 mV @2kΩ, ±10% | / | 688 mV @2kΩ, ±10% | 2.48V @ 2kΩ | -122V @ 2kΩ | | Voltage | 3.86 V @10kΩ, ±10% | | 3.4 V @10kΩ, ±10% | 10.6V @ 10kΩ | -348V @ 10kΩ | | Maximum Output Current | 450 μA @500Ω, ±10% 450 μA @2kΩ, ±10% 386 μA @10kΩ, ±10% | | 243 μA @500Ω, ±10% 245 μA @2kΩ, ±10% 246 μA @10kΩ, ±10% | 2.98mA @ 500Ω 1.24mA @ 2kΩ 1.06mA @ 10kΩ | 500 μA 363 μA @500Ω, ±20% 117 μA @2kΩ, ±20% 38 μA @10kΩ, ±20% | | Pulse Period (Pulse Width) | 4ms | / | Varies w/Frequency (60 msec @ 8.33Hz) | 4ms | 1.1 | | Output Frequency (Hz) | 57±3Hz | / | 0.3 - 50 Hz (Default 8.3 Hz) | 60Hz | 15 to 121 | | Net Charge | 0 μC @ 500Ω | / | 0 μC @ 500Ω | 0 μC @ 500Ω | 4 μC @ 500Ω | | Maximum current density | 0.49mA/cm²@500Ω | / | Trinity ELE Plus 0.947 mA/cm² @ 10k Ω Trinity ELE Plus Pro 1.165 mA/cm² @ 10k Ω | 0.524mA/cm² @500Ω | Built-in, Y, Brush: 800 μA/cm² @500Ω Pencil: 19,000 μA/cm² @500Ω | | Maximum Power | 0.20mW/cm²@ 500Ω | / | Trinity ELE Plus 2.331 mW/cm² @ 10k Ω | 0.216mW/cm² @500Ω | Built-in, Y, Brush: 500μW/cm² @500Ω | {11}------------------------------------------------ Micro-current vibration facial cold and hot service, Model: TPML-100 Subject Device: | Density | | | Trinity ELE Plus Pro | | Pencil: | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | | | | $3.525 mW/cm² @ 10K Ω$ | | $3,500μW/cm² @500Ω$ | | Treatment recommendat ion | Hold treatment face in contact with skin. Apply blue light for 3 minutes per skin area, followed by red light for 3 minutes per skin area. Can be used daily. Apply EMS micro-current for 15 minutes per day. Can be used for 2-3 times per week. | Hold treatment face in contact with skin. Apply blue light for 3 minutes per skin area, followed by red light for 3 minutes per skin area. Can be used daily. | Unknown | 15 minutes | max duration of use: 60 minutes | | Main Materials | PC, ABS, Stainless steel (SUS 304) | Rigid ABS Polycarbonate lens cover | ABS Thermoplastic Chromium | PC, ABS, Stainless steel (SUS 304) | Stainless steel 316 | | Dimension | 188(L)×50(W)×55(H)mm | 257mm×165mm×70mm (10.1in×6.5in×2.8in) | 6.1" H x 2.4" W x 1.2" D | -- | 2.6" X 4.7" X 1.35" | | Net Weight | 233 g | 174g (6.1 oz) | Unknown | -- | 5.4 ounces | | Safety and EMC | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-10 IEC 60601-2-57 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-10 IEC 60601-2-57 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-10 ISO 14971 IEC 62366 | | Biocompatibil ity | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | / | {12}------------------------------------------------ ## 8. Summary for clinical test No Clinical Test conducted. ## 9. Usability Testing Usability testing was conducted to demonstrate that the device and its labeling can meet the following requirements: 1) the lay user can self-select themselves as being appropriate users of this device by the external box labeling, 2) the lay user can apply the treatment safely and correctly according to the instructions for use, and 3) the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual. ## 10. Conclusion The subject device Micro-current vibration facial cold and hot service has all features of the predicate devices for intended use. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.

Micro-current facial cold and hot service (model: TPML-100)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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Micro-current facial cold and hot service (model: TPML-100)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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