AliTight

K231146 · Alic Iotech, LLC · GEI · Sep 8, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231146
• Device Name: AliTight
• Applicant: Alic Iotech, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AliTight device is intended for use in the non-invasive heating of facial skin.

Device Story

AliTight delivers 1MHz bipolar RF current to facial skin; generates heat via electrical impedance in dermis and subcutaneous layers. Device consists of handheld unit and power supply. Integrated temperature sensor between electrodes monitors skin temperature; automatically disables/reduces RF transmission upon reaching target temperature. Used for non-invasive heating. Operated by clinician (prescription use). Output provides controlled thermal energy to skin; intended to benefit patient through non-invasive heating.

Clinical Evidence

Bench testing only. Verification testing confirmed system technical specifications for RF power output and over-heating safety mechanisms. Software validation performed per FDA guidance. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-2, and IEC 62304 standards demonstrated.

Technological Characteristics

RF bipolar energy source; 1MHz carrier frequency; 5W max RMS power; 4 electrodes. Integrated temperature sensor for safety shut-off. Dimensions: 161mm x 64mm x 52mm; Weight: 142g. Power: 100-240VAC input, 12V DC output. Biocompatibility per ISO 10993-1. Software lifecycle per IEC 62304. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-2.

Indications for Use

Indicated for non-invasive heating of facial skin.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Pollogen Ltd., STOP U (K140255)

Submission Summary (Full Text)

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September 8, 2023

Alic Iotech, LLC Like Zeng Official Correspondent 8165 Mountain View Dr Unit D Pleasanton, California 94588

Re: K231146

Trade/Device Name: AliTight Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: April 21, 2023 Received: August 15, 2023

Dear Like Zeng:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Colin K. Chen -S

for

Mark Trumbore, Ph.D. 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

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## Indications for Use

Submission Number (if known)

K231146

Device Name

AliTight

Indications for Use (Describe)

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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# K231146

# 510(k) SUMMARY

### AliTight Device

Applicant's Name: ALIC IOTECH, LLC 8165 Mountain View Dr Unit D Pleasanton, CA 94588 U.S.A. Tel. [phone]

Contact Person: Like Zeng 8165 Mountain View Dr Unit D Pleasanton, CA 94588 U.S.A. Tel. [phone] Email: [e-mail]

- Date Prepared: September 6th, 2023
- Name of Device: AliTight

Common or Usual Name: Electrosurgical cutting and coagulation device and accessories

- Classification: Product Code: GEI Regulation No: 21 C.F.R. §878.4400 Class: II Classification Panel: General & Plastic Surgery
- Pollogen Ltd., STOP U (K140255) Predicate Devices:

#### Intended Use / Indications for Use

The AliTight device is intended for use in the non-invasive heating of facial skin.

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### Device Description

The AliTight device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the AliTight device and the AliTight power supply.

### Comparison of Technological Characteristics

The AliTight device delivers RF energy at a frequency of 1MHz and a maximum output RMS power of 5 watts into the skin through its electrodes. The device generates heat through electrical impedance in the dermis and subcutaneous layers. The temperature sensor, located between the electrodes constantly monitors the skin temperature and disables RF transmission once the desired skin temperature is obtained.

The following table compares the AliTight device to the predicate devices with respect to technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

| Description | Proposed Device<br>AliTight | Predicate Device 1<br>STOP U (K140255) |
|--------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Class of Device | II | II |
| Classification Panel | General & Plastic Surgery | General & Plastic Surgery |
| Regulation Number | 21 C.F.R. §878.4400 | 21 C.F.R. §878.4400 |
| Regulation Description | Electrosurgical cutting and<br>coagulation device and accessories | Electrosurgical cutting and coagulation<br>device and accessories |
| Product Code | GEI | GEI |
| Prescription or OTC | Prescription | Prescription |
| Deep Tissue Heating<br>Electromagnetic<br>Energy | Radiofrequency (RF) | Radiofrequency (RF) |
| Mode of Operation | RF Bipolar energy | RF Bipolar energy |
| RF Carrier Frequency | 1 MHz | 1 MHz |
| Waveform | Sinusoid | Sinusoid |
| Nominal Operating RF<br>Power (200 Ohms) | 5W | 5.7W |
| Number of Electrodes | 4 | 4 |

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| Description | Proposed Device<br>AliTight | Predicate Device 1<br>STOP U (K140255) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | 161mm L x 64mm W x 52mm H | H=134mm; L=51mm; W=32mm |
| Weight | 142gr | 85 gr |
| Energy Source | 100 - 240VAC, 50-60Hz, 500mA | 100-240V, 50-60Hz, 600mA |
| Output Voltage | 12 V DC | 8V DC |
| Safety Mechanism | The temperature sensor, located<br>between the electrodes constantly<br>monitors the skin temperature and<br>disables/reduces RF transmission<br>once the desired skin temperature<br>is obtained | The temperature sensor, located<br>between the electrodes constantly<br>monitors the skin temperature and<br>disables RF transmission once the<br>desired skin temperature is obtained |
| Biocompatibility | All parts that are in contact with<br>patient comply with the<br>requirements of ISO 10993-1 | All parts that are in contact with patient<br>comply with the requirements of ISO<br>10993-1 |
| Software | Verified and validated according<br>to the FDA guidance | Verified and validated according to the<br>FDA guidance |

## Performance Data

ALIC IOTECH conducted several performance tests to demonstrate that the AliTight device complies with performance standards and that it functions as intended.

- . Verification test demonstrating that the AliTight device meets the system's technical specifications for the over-heating safety and RF power output.
- The AliTight device software was validated as required. ●

In all instances the AliTight device functioned as intended and observations were as expected.

## Performance Standards

The AliTight device complies with the following performance standards:

- . IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (2005/AMD1:2012)
- . IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests (2014, Ed.4)
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General requirements for safety -. Collateral Standard: Usability (2010, AMD1:2013, AMD2:2020)

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- IEC 60601-1-11 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 (2015, Ed.2)
- IEC 60601-2-2 Medical Electrical Equipment Part 2-2: Particular requirements for the ● basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (2017, Ed.6.0)
- IEC 62304 Medical device software Software life cycle processes (2006, Ed. 1/AMD . A1:2015)

## Conclusion

The subject AliTight device is indicated for non-invasive heating of facial skin. The subject device principles of operation and technological characteristics do not raise new or different questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device.