(315 days)
Not Found
No
The device description and performance studies focus on basic electrical and mechanical functions, with no mention of AI/ML terms or data-driven features.
No
The device is indicated for over-the-counter cosmetic use and facial stimulation, not for treating or diagnosing any medical condition.
No.
The device's intended use is for "facial stimulation" and "at-home cosmetic use," with no mention of diagnosing any medical condition or disease.
No
The device description explicitly mentions hardware components like dual probes, mechanical vibration, and micro-current impulses, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "facial stimulation" and "over-the-counter cosmetic use." This is a physical/electrical stimulation device for cosmetic purposes, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description details mechanical vibration and micro-current impulses applied externally to the face. This aligns with a physical therapy or cosmetic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
Therefore, based on the provided text, the SonicLift (Model: ST261) is a cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
Product codes (comma separated list FDA assigned to the subject device)
NFO, IRO
Device Description
SonicLift (Model: ST261) is a non-invasive facial toning device intended for at-home cosmetic use. It has two treatment modes - Vibration Mode and Micro-current Mode. In the Vibration Mode, mechanical vibration at the frequency of 108.7Hz can help to relax facial muscles. In the Micro-current Mode, the low voltage micro-current impulses are emitted from dual probes that are designed for optimal contact with faces of all shapes and sizes. SonicLift, Model: ST261 allows you to adjust the current output from 0 to 280 microamps for a personalized comfort level.
The SonicLift (Model: ST261) is not for use on injured or otherwise impaired skin or muscles, and in any therapy for the treatment, or prevention of any disease. This device is not for use near any devices with Electromagnetic Interference (EMI), such as cell phones, MRI, CT, RFID etc. or MR environment. This device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper.
The conductive gel used along with the SonicLift, Model: ST261 is the K983964 Batch #6060 Conductive Gel (Skylark Device CO. LTD).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Facial muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
at-home cosmetic 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)
SonicLift, Model: ST261 has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to verify the output parameters of the device.
Biocompatibility tests:
- Cytotoxicity Test: MTT Method in ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, Edition 3.0, 2009. Passing Criteria: "no more than Grade 2" according to United States Pharmacopoeia. Test Result: The Cytotoxicity test result showed the device had no toxicity to L929 cell. The test result is passed the criteria.
- Skin Sensitization Test: Guinea Pig Maximization Test in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010. Passing Criteria: "Grade 0" according to United States Pharmacopoeia. Test Result: The Skin Sensitization test result for device is Grade 0. The test result is passed the criteria.
- Skin Irritation Test: 0.9% Sodium Chlorid Injection and Sesame oil Extract in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010. Passing Criteria: "0-0.4 for Irritation Index" according to United States Pharmacopoeia. Test Result: The Skin Irritation test results for Component is 0 for Irritation Index. The test result is passed the criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them. The profiles are silhouetted in black, and the overall design is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
Pretika Corporation Thomas Nichols President 12215 Holly Street Riverside, California 92509
Re: K150077
Trade/Device Name: SonicLift, Model ST261 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO, IRO Dated: January 4, 2015 Received: February 19, 2015
Dear Thomas Nichols:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena - S//
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150077
Device Name SonicLift, Model: ST261
Indications for Use (Describe)
This device is intended for facial stimulation and is indicated for over-the-counter cosmetic 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)
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3
Sponsor: Pretika Corporation Subject Device: SonicLift, Model: ST261 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement File No.:
Chapter 6. 510(k) Summary
Date of the summary prepared: November 24, 2015
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
- � 510(k) Owner's Name: Pretika Corporation
- � Establishment registration number: Applying
- Address: 12215 Holly Street, Riverside, CA 92509 USA �
- � Phone: 949-481-8818
- Fax: 949-481-8828 �
- Contact Person (including title): Thomas Nichols (president) �
- E-mail: thomasnichols@pretika.com �
2. Subject Device Information
- � Trade Name: SonicLift, Model: ST261
- Facial Toning Device Common Name: �
- Transcutaneous Electrical Nerve Stimulator for Aesthetic � Classification name:
- Purposes
- Neurology, Physical Medicine � Review Panel:
- nfo, Iro Product Code: �
- 2 � Regulation Class:
- 882.5890, 890.5975 Regulation Number: �
3. Predicate Device Information
| Sponsor | Carol Cole Company | WAHL CLIPPER CORP |
|---|---|---|
| Device Name | NuFace | WAHL FRESH FACE |
| 510(k) Number | K072260 | K944909 |
| Product Code | NFO | IRO |
| Regulation | ||
| Number | 882.5890 | 890.5975 |
4
Sponsor: Pretika Corporation Subject Device: SonicLift, Model: ST261 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement File No.:
| Regulation Class | 2 | 1 |
|---|---|---|
| ------------------ | --- | --- |
4. Device Description
SonicLift (Model: ST261) is a non-invasive facial toning device intended for at-home cosmetic use. It has two treatment modes - Vibration Mode and Micro-current Mode. In the Vibration Mode, mechanical vibration at the frequency of 108.7Hz can help to relax facial muscles. In the Micro-current Mode, the low voltage micro-current impulses are emitted from dual probes that are designed for optimal contact with faces of all shapes and sizes. SonicLift, Model: ST261 allows you to adjust the current output from 0 to 280 microamps for a personalized comfort level.
The SonicLift (Model: ST261) is not for use on injured or otherwise impaired skin or muscles, and in any therapy for the treatment, or prevention of any disease. This device is not for use near any devices with Electromagnetic Interference (EMI), such as cell phones, MRI, CT, RFID etc. or MR environment. This device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper.
The conductive gel used along with the SonicLift, Model: ST261 is the K983964 Batch #6060 Conductive Gel (Skylark Device CO. LTD).
5. Intended Use / Indications for Use
The device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
6. Materials
There are four user directly contracting components in the subject device as the following list.
| Component of
Device Requiring
Biocompatibility | Material of
Component | Body Contact
Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------|
| Housing | ABS plastic | Surface-contacting
device: skin | Maximum 2 hours
(Basic Unit Characteristics | | | | |
| Power Source(s) | 3.7V li-battery | 9V AAA batteries | --
SE
Note 1 | |
| Method of Line
Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part
SE | |
| Patient
Leakage
Current | NC
SFC | Comply with IEC 60601-
1 and IEC 60601-2-10 | --
SE
Note 1 | |
| Average DC
current through
electrodes when
device is on but
no pulses are
being applied | 0A | -- | --
SE
Note 1 | |
| Number of Output
Channels | One channel | One channel | One channel
SE | |
| Number of Output
Modes | 2 modes | 1 mode | --
SE
Note 1 | |
| Elements of
Comparison | Subject Device | Predicate Device | Remark | |
| Output Intensity
Level | 4 steps | 2 steps | SE
Note 1 | |
| Synchronous or
Alternating? | N/A | Alternating | SE | |
| Method of
Channel Isolation | N/A | Voltage Isolation | SE | |
| Regulated Current
or Regulated
Voltage? | Current Control | Current Control | SE | |
| Software/Firmwar
e/Microprocessor
Control? | Yes | Yes | SE | |
| Automatic
Overload Trip | No | No | SE | |
| Automatic No-
Load Trip | No | No | SE | |
| Automatic Shut
Off | No | No | SE | |
| Patient Override
Control | Yes | Yes | SE | |
| Indicator
Display | On/Off
Status | Yes | Yes | SE |
| | Low
Battery | Yes | No | SE
Note 1 |
| | Voltage/
Current
Level | Yes | No | SE
Note 1 |
| Timer Range | No | No | SE | |
| LCD Display | No | Indicate the following
information: on/off status,
low battery | SE
Note 1 | |
| Compliance with
Voluntary
Standards | Yes
Comply with IEC 60601-
1 and IEC 60601-2-10,
IEC 60601-1-2 | Yes
Comply with IEC 60601-1
and IEC 60601-2-10, IEC
60601-1-2 | SE | |
| Compliance* with | Yes | Yes | SE | |
| Elements of
Comparison | Subject Device | Predicate Device | Remark | |
| 21 CFR 898 | | | | |
| Weight | Main unit: 248g
Charge station: 200g
Charger Adapter: 180g | 816g | SE
Note 2 | |
| Dimensions | 3.7" L x 7.6" W x 2.8" D | 177.8 x 63.5 x 25.4 mm
(7" L x 2.5" W x 1" D) | SE
Note 2 | |
| Electrode Size | 16 cm² | -- | SE
Note 2 | |
| Housing Materials
and Construction | ABS plastic | ABS plastic | SE | |
| Output Specifications | | | | |
| Waveform | Pulsed Biphasic | Pulsed Monophasic | SE
Note 3 | |
| Shape | Rectangular | Rectangular | SE | |
| Maximum Output
Voltage(+/- 10%) | 156mV @ 500Ω
0.78V @ 2kΩ
2.6V@10KΩ | 0.158V@ 500Ω
0.78V@ 2KΩ
2.6V@ 10KΩ | SE
Note 3 | |
| Maximum Output
Current(+/- 10%) | 0.31mA @ 500Ω
0.39mA @ 2kΩ
0.26mA @ 10kΩ | 0.223mA@ 500Ω
0.358mA@ 2KΩ
0.263mA@10KΩ | SE
Note 3 | |
| Pulse Duration | 112 ms | 112 ms | SE | |
| Pulse Frequency | 8.93Hz | 8.93Hz | SE | |
| Net Charge (per
pulse) | 0mC @ 500Ω | 0.0062µC @ 500Ω | SE
Note 3 | |
| Maximum
Average Current | 0.198mA @500Ω | -- | SE
Note 3 | |
| Maximum Current
Density
(r.m.s ) | 0.0194mA/cm²@500Ω
(The Electrode Size:
16cm²) | 0.341 mA/cm²@500Ω | SE
Note 3 | |
| Maximum
Average Power
Density | 3µW/cm²@500Ω(The
Electrode Size:16cm²) | 3.02µW/cm²@500Ω | SE
Note 3 | |
| Contraction and
Relaxation Time | Adjustable, due to
different modes. (See
below "Program
Specification Table") | Adjustable, due to different
modes. | SE | |
| Elements of
Comparison | Subject Device | Predicate Device | Remark | |
| Additional Features | | | | |
| Environment for
operating | Temperature: 5 ~ 40°C
Humidity: ≤ 80% RH | Temperature: 5 ~ 40° C
Humidity: 20 ~ 65% RH | SE
Note 1 | |
| Environment for
storage | Temperature: 0 ~ 45°C
Humidity: ≤ 93% RH | Temperature: 0 ~40°C
Humidity: 10 ~90%RH | SE
Note 1 | |
| Standards | | | | |
| Biocompatibility | All user directly
contacting materials are
compliance with
ISO10993-5 and
ISO10993-10
requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | SE | |
| Electrical Safety | Comply with IEC 60601-
1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | SE | |
| EMC | Comply with IEC 60601-
1-2 | Comply with IEC 60601-1-2 | SE | |
9
Pretika Corporation Sponsor: Subject Device: SonicLift, Model: ST261 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement File No.:
10
Pretika Corporation Sponsor: Subject Device: SonicLift, Model: ST261 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement File No.:
11
Sponsor: Pretika Corporation Subject Device: SonicLift, Model: ST261 File No.: 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement
Comparison in Detail(s):
Note 1:
Some of the basic unit characteristics, such as "Power Source(s)", " Weight", " Dimensions", "Operating Environment", "Storage Environment", "Number of Output Intensity Level" and "Indicator Display of Voltage/ Current Level" are a little different from the predicate devices. However, it will not affect the main function and the intended use of the device as they all also comply with IEC 60601-1 requirements. Bisides, the subtle changes of the physical characteristics will not affect the critical functions or the normal use.So the differences will not raise any safety or effectiveness issue.
Note 2:
Although some of the simulation characteristics, such as " Maximum Output Voltage(+/- 10%)", "Maximum Output Current(+/- 10%)", "Pulse Duration", "Pulse Frequency" and "Net Charge (per pulse)" of subject device are different from the simulator predicate device Nuface, they are all proved by waveform report and performance report. And they comply with IEC 60601-2-10 requirements, FDA guidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning. So the differences of the physics specifications will not raise any safety or effectiveness issue.
12
Note 3:
Although the "Maximum Output Voltage", "Maximum Output Current", "Net Charge (per pulse)", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density" of subject device are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement, FDA guidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning. So the differences of function specification will not raise any safety or effectiveness issue.
Finial Conclusion:
The subject device "SonicLift, Model: ST261" is Substantial Equivalence to all predicate devices.