(140 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on RF heating technology and standard performance testing.
Yes
The device explicitly states its intended use is for "non-invasive heating of facial skin," which implies a therapeutic effect (e.g., skin tightening, wrinkle reduction, etc.), making it a therapeutic device. Additionally, its classification as "Prescription Use" further suggests a medical or therapeutic application.
No
The device is described as being for "non-invasive heating of facial skin" and delivering "RF current into the skin to generate heat," which indicates a therapeutic rather than a diagnostic function. There is no mention of it detecting, identifying, or monitoring any medical conditions.
No
The device description explicitly states that the device consists of the "AliTight device and the AliTight power supply," indicating hardware components are included. The performance studies also mention verification tests for "over-heating safety and RF power output," which are hardware-related parameters.
Based on the provided information, the AliTight device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "non-invasive heating of facial skin." This describes a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: The device delivers RF current into the skin to generate heat. This is an energy-based treatment applied externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The AliTight device does not involve the analysis of any biological specimens.
Therefore, the AliTight device falls under the category of a therapeutic or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AliTight device is intended for use in the non-invasive heating of facial skin.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pollogen Ltd., STOP U (K140255)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
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
1
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
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)
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. +1 (520) 907-1679
Contact Person: Like Zeng 8165 Mountain View Dr Unit D Pleasanton, CA 94588 U.S.A. Tel. +1 (520) 907-1679 Email: soarmichael@gmail.com
- 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.
4
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
AliTight | Predicate Device 1
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
coagulation device and accessories | Electrosurgical cutting and coagulation
device and accessories |
| Product Code | GEI | GEI |
| Prescription or OTC | Prescription | Prescription |
| Deep Tissue Heating
Electromagnetic
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
Power (200 Ohms) | 5W | 5.7W |
| Number of Electrodes | 4 | 4 |
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| Description | Proposed Device
AliTight | Predicate Device 1
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
between the electrodes constantly
monitors the skin temperature and
disables/reduces RF transmission
once the desired skin temperature
is obtained | The temperature sensor, located
between the electrodes constantly
monitors the skin temperature and
disables RF transmission once the
desired skin temperature is obtained |
| Biocompatibility | All parts that are in contact with
patient comply with the
requirements of ISO 10993-1 | All parts that are in contact with patient
comply with the requirements of ISO
10993-1 |
| Software | Verified and validated according
to the FDA guidance | Verified and validated according to the
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.