The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use.
LED functional mode
- To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face.
- To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne.
Vibrating massage functional mode
As an electrically powered device intended for medical purposes to relieve minor aches and pains.
Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 is a device provided with two operation functions: Vibrating massage and LED light irradiation. The product provided with internal battery and it can be charged by external adaptor.
For LED light irradiation functional, the device provides with two LED irradiation modes: Blue Light working Mode, Blue and Red Light working Mode, which can be switched by Mode button. When the device works in red and blue light working mode, the device provides spectral emission with LED red light (630±10nm) and blue light (415±10nm). In blue light working mode, the device only provide LED blue light output (415±10nm) by the LED lamp module in treatment head.
When the device works in Vibrating massage mode, the vibration can be provided on the stainless steel contactor in treatment head and can provide vibrating massage to facial skin.
The provided document is a 510(k) summary for the "Photon Vibrating massage Facial Aesthetic Device, Model: UI-200." This document primarily focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on studies involving clinical outcomes or diagnostic accuracy. The key "study" described is a usability and self-selection study for an over-the-counter device.
Therefore, many of the typical acceptance criteria and study details for an AI/ML diagnostic device (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and product.
However, I can extract the relevant information regarding the usability study and present the device's technical specifications as its "performance" against its design requirements (which serve as a form of internal acceptance criteria).
Device Acceptance Criteria and Performance (Based on Technical Specifications and Usability Study)
Given that this is a 510(k) submission for an over-the-counter facial aesthetic device, the "acceptance criteria" are primarily related to its safety, electrical performance, biocompatibility, and user-friendliness for lay users, rather than diagnostic accuracy metrics. The "study" described is a usability and self-selection study.
1. Table of Acceptance Criteria (Design Requirements) and Reported Device Performance
| Acceptance Criteria (Related to Device Specifications/Safety) | Reported Device Performance (as tested) | Remarks / Relevance |
|---|---|---|
| LED Functional Mode Parameters | ||
| LED Wavelength (Red) | 630 ± 10 nm | Meets specified range. |
| LED Wavelength (Blue) | 415 ± 10 nm | Meets specified range. |
| LED Power Density (Blue) | 22 mW/cm² | Meets specified value. |
| LED Power Density (Red) | 7.5 mW/cm² | Meets specified value. |
| Vibrating Massage Functional Mode Parameters | ||
| Vibration Frequency (Level 1) | 2.98 MHz | Meets specified range (3MHz ± 5%). |
| Vibration Frequency (Level 2) | 2.96 MHz | Meets specified range (3MHz ± 5%). |
| Vibration Frequency (Level 3) | 2.97 MHz | Meets specified range (3MHz ± 5%). |
| Vibration Frequency (Level 4) | 2.97 MHz | Meets specified range (3MHz ± 5%). |
| Vibration Frequency (Level 5) | 2.97 MHz | Meets specified range (3MHz ± 5%). |
| Output Power | 0.16W | Specified and reported. |
| Biocompatibility | ||
| Compliance with ISO 10993-5 (Cytotoxicity) | Compliance with ISO10993-5 requirements. | Ensured for direct patient contact. |
| Compliance with ISO 10993-10 (Sensitization/Irritation) | Compliance with ISO10993-10 requirements. | Ensured for direct patient contact. |
| Electrical Safety | ||
| Compliance with IEC 60601-1 | Comply with IEC 60601-1 | Basic safety standard for medical electrical equipment. |
| Compliance with IEC 60601-2-57 | Comply with IEC 60601-2-57 | Specific standard for light sources for aesthetic and therapeutic use. |
| Patient leakage current | Comply with IEC 60601-1 | Ensured for patient safety. |
| Electromagnetic Compatibility (EMC) | ||
| Compliance with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Ensures device does not interfere with, or is interfered by, other electrical equipment. |
| Software Verification & Validation | Test conducted | Confirms software functions as intended (per FDA guidance). |
| Usability/Self-Selection for Lay Users | ||
| Ability to properly self-select using labeling | 100% of lay users able to properly self-select. | Crucial for over-the-counter devices to ensure appropriate use. |
| Ability to properly use the device by reading instructions | 100% of lay users able to properly use w/o assistance. | Ensures safe and effective use by target audience. |
2. Sample size used for the test set and the data provenance
For the Usability Study:
- Sample Size: Not explicitly stated as a number, but the report mentions that "Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended" and "100% of lay users were able to properly self-select themselves using the box labeling and all lay users were able to properly use the device by reading instructions in the user manual without any assistance." While a specific number of participants is not provided, the 100% success rate implies a sample size that was deemed sufficient for this over-the-counter device's usability claim, likely a small, representative group of lay users.
- Data Provenance: Not specified (e.g., country of origin). The study was likely prospective, conducted specifically for this submission to demonstrate lay user comprehension and self-selection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML diagnostic device, and the usability study's "ground truth" was simply the observation of whether lay users could successfully self-select and operate the device based on provided instructions. Expert medical opinion was not required for this type of assessment.
4. Adjudication method for the test set
Not applicable. There was no complex "ground truth" requiring adjudication. The assessment was a direct observation of user behavior against clear operational objectives.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML diagnostic device, nor does it involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical non-AI/ML medical device.
7. The type of ground truth used
The "ground truth" for the usability study was the successful completion of tasks by lay users as described in the device's labeling and user manual. This is a direct observational outcome. For the technical specifications, the ground truth was derived from laboratory bench testing (e.g., electrical safety, EMC, wavelength, power density measurements).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
Li-Tek Electronics Technologies c/o Shiling Li Guangzhou KunSBo Managing Consultancy Co., Ltd Building H, No 199 Kezhu Road, Guangzhou Science City Guangzhou, Guangdong Province, China 510000
Re: K161434
Trade/Device Name: Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) 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 Dated: August 23, 2017 Received: September 1, 2017
Dear Shiling 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. 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
{1}------------------------------------------------
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (21CFR 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, Jennifer R. Stevenson -53 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161434
Device Name
Photon Vibrating Massage Facial Aesthetic Device , Model: UI-200
Indications for Use (Describe)
The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use. LED functional mode
- To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face.
- To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne.
Vibrating massage functional mode
As an electrically powered device intended for medical purposes to relieve minor aches and pains.
| 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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510(k) Summary
Date of the summary prepared: September 28, 2017
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: Li-Tek Electronics Technology Corporation
- Establishment registration number: Applying �
- Address: No. 8~13, Industrial Park of Jinshagang, Shixia village, Dalang town, Dongguan � city, Guangdong, China
- Phone: 0769-83117755 �
- Fax: 0769-83117754 �
- Contact Person (including title): Barry Yuan (Quality Director) �
- � E-mail: quality5@li-tek.com
2. Application Correspondent
- � Contact person: Mr. Jet Li
- Company name: Guangzhou KunSBo Managing Consultancy Co., Ltd �
- Tel: +86-18588874857 �
- � Email: med-jl@foxmail.com
3. Subject Device Information
| ◆ | Trade Name: | Photon Vibrating massage Facial Aesthetic Device, ModelUI-200 |
|---|---|---|
| ◆ | Common Name: | Acne Light Therapy System |
| ◆ | Classification name: | Over-the-counter powered light based laser for acne;Therapeutic massager |
| ◆ | Review Panel: | General & Plastic Surgery, Physical Medicine |
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- OLP, ISA Product Code: �
- � Regulation Class: 2
- � Regulation Number: 878.4810, 890.5660
Predicate Device Information a)
| Sponsor | Accord Media | Syneron Beauty Inc. | NutraLuxe MD, LLC |
|---|---|---|---|
| Device Name | Ultra Renew Plus | Tanda Mini SkincareSystem | Pulsaderm AcneDevice |
| 510(k) Number | K132833 | K124042 | K161941 |
| Product Code | OLP, OHS, ISA | OLP | OLP |
| RegulationNumber | 878.4810, 890.5660 | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 | 2 |
4. Device Description
Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 is a device provided with two operation functions: Vibrating massage and LED light irradiation. The product provided with internal battery and it can be charged by external adaptor.
For LED light irradiation functional, the device provides with two LED irradiation modes: Blue Light working Mode, Blue and Red Light working Mode, which can be switched by Mode button. When the device works in red and blue light working mode, the device provides spectral emission with LED red light (630±10nm) and blue light (415±10nm). In blue light working mode, the device only provide LED blue light output (415±10nm) by the LED lamp module in treatment head.
When the device works in Vibrating massage mode, the vibration can be provided on the stainless steel contactor in treatment head and can provide vibrating massage to facial skin.
5. Intended Use / Indications for Use
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The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use.
LED functional mode
-
To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face.
-
To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne.
Vibrating massage functional mode
As an electrically powered device intended for medical purposes to relieve minor aches and pains.
6. Design
Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 is a device provided with two operation functions: Vibrating massage and LED light irradiation. The product provided with internal battery and it can be charged by external adaptor.
For LED light irradiation functional, the device provides with two LED irradiation modes: Blue Light working Mode, Blue and Red Light working Mode, which can be switched by Mode button. When the device works in red and blue light working mode, the device provides spectral output with LED red light (630±10nm) and blue light (415±10nm). In blue light working mode, the device only provide LED blue light output (415±10nm) by the LED lamp module in treatment head.
When the device works in Vibrating massage mode, the vibration can be provided on the stainless steel contactor in treatment head and can provide vibrating massage to facial skin. For aforementioned three operation modes, they can only operate separately.
7. Materials
There is one of patient directly component in the subject device as the following list.
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| Device RequiringBiocompatibility | Component | Category(ISO 10993-1) | (ISO 10993-1) |
|---|---|---|---|
| stainless steeltreatment head forvibrating massage | Stainless steel | Surface-contactingdevice: skin | Maximum 2 hours(< 24hours) |
The Nature of body contact is surface-skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:
- ◆ Cytotoxicity
- ◆ Sensitization
- ◆ Irritation or intracutaneous reactivity
8. Physical characteristics
| Table I | |
|---|---|
| Basic Unit Characteristics | |
| Method of Line Current Isolation | Type BF Applied Part |
| Compliance* with 21 CFR 898 | Yes |
| Main Unit Weight | 180g |
| Main Unit Dimension | 3.7" L x 7.6" W x 2.8" D |
| Housing Materials of main unit | Housing made from ABS plastic and output contactsmade from stainless steel. |
| Indicator | Indicates low battery, working mode information,intensity level for vibrating massage mode. |
| Time Range (minutes) | 1-20 mins |
| Environment for operation | Temperature: 5°C~40°CHumidity: ≤ 80% |
| Compliance with VoluntaryStandards | YesComply with IEC 60601-1, IEC 60601-2-57, IEC60601-1-2 |
| Patient leakage current | Comply with IEC 60601-1 |
| Power Source | 3.7V 1000mAh Li battery |
| Software/Firmware/MicroprocessorControl? | Yes |
Table I
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| Humidity: ≤ 80% | |
|---|---|
| Environment for Storage | Temperature: 0 ~ 45°CHumidity: ≤ 93% RH |
| Biocompatibility | Compliance with ISO10993-5 and ISO10993-10requirements. |
| Electrical Safety | Comply with IEC 60601-1, and IEC60601-2-57 |
| EMC | Comply with IEC 60601-1-2 |
- For Vibrating massage Mode:
Table II Vibration intensity level Level 1 Level 2 Level 3 Level 4 Level 5 on output contactor Frequency for 2.98MHz 2.96MHz 2.97MHz 2.97MHz 2.97MHz ultrasonic wave Vibrator massage 84 us 105 us 144 us 124 us 164 us pulse Vibrator massage 196.3 Hz 195.5 Hz 194.7Hz 193.9 Hz 193.2 Hz frequency Output Power 0.16W
2) For LED light mode: Blue mode and Red Mode
| Table III | |
|---|---|
| LED Wavelengths | Red: 630±10nm, Blue: 415±10nm |
| LED power density | Blue: 22 mW/cm² |
| Red: 7.5 mW/cm² |
10. Test Summary
Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 has been evaluated the safety and performance by lab bench testing as following:
- ◆ Electrical safety test according to IEC 60601-1 Edition 3.0: 2005+A1:2012 and IEC60601-2-57 Edition 1.0: 2011
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- � Electromagnetic compatibility test according to IEC 60601-1-2 Edition 4.0: 2014 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 vibration massage pulse's parameters of the device.
11. Usability study and self-selection study summary
A lay-user study and self-selection study was conducted and oversight to determine if lay users could read the product labeling and then self assess if the device would be appropriate for them to use. Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that 100% of lay users were able to properly self-select themselves using the box labeling and all lay users were able to properly use the device by reading instructions in the user manual without any assistance. In summary, the conclusion was that an average lay user can read and comprehend correctly the user manual and package labeling.
12. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Device Nameand Model | Photon Vibrating massageFacial Aesthetic Device,Model: UI-200 | Tanda Mini Skincare System | Pulsaderm Acne Device | -- |
| 510(k) Number | Applying | K124042 | K161941 | -- |
| Product Code | OLP, ISA | OLP | OLP | -- |
| Manufacturer | Li-Tek Electronics | Syneron Beauty Inc. | NutraLuxe MD, LLC | -- |
| Elements ofComparison | Subject Device | Predicate Device | Remark | |
| Technologies | ||||
| Intended Use | The Photon Vibratingmassage Facial AestheticDevice (Model: UI-200) isintended forover-the-counter use.LED functional mode- To emit energy in the blueand red region of thespectrum, specifically totreat mild to moderate acneon the face.- To emit energy in the blueregion of the spectrum totreat mild to moderateinflammatory acne.Vibrating massagefunctional modeAs an electrically powereddevice intended for medicalpurposes to relieve minoraches and pains. | The Tanda Mini SkincareSystem is generally indicatedto treat dermatologicalconditions. Specifically, bluelight modules are indicated totreat mild to moderateinflammatory acne. | Pulsaderm Acne Device isintended to emit energy in thered and blue region of thespectrum, specificallyindicated to treat mild tomoderate acne on the face.SENote 1 | |
| Basic Unit Characteristics | ||||
| PowerSource(s) | 3.7V 1000mAh Li battery | Battery operated | SE | |
| Method of LineCurrentIsolation | Type BF Applied Part | Type BF Applied Part | SE | |
| Weight | 180g | -- | SENote 2 | |
| Dimensions | 3.7" L x 7.6" W x 2.8" D | -- | SENote 2 | |
| HousingMaterials andConstruction | Housing made from ABSplastic and output contactsmade from stainless steel | -- | SENote 2 | |
| Elements ofComparison | Subject Device | Predicate Device | Remark | |
| Output Specifications | ||||
| Energy Type | LED | LED | LED | SE |
| LED lightWavelengths | Red: 630 ± 10 nm,Blue: 415 ± 10 nm | Blue:414nm ± 6 nm | Red: 630 ± 5 nm,Blue: 415 ± 5 nm | SENote 3 |
| LED light PowerDensity | Blue: 22 mW/cm²Red: 7.5 mW/cm² | Blue:22.4 mW/cm² | Blue: 20 mW/cm²Red: 5 mW/cm² | SENote 4 |
| Additional Features | ||||
| Environment forOperating | Temperature: 5 ~ 40°CHumidity: ≤ 80% | -- | SENote 5 | |
| Environment forStorage | Temperature: 0 ~ 45°CHumidity: ≤ 93% RH | -- | SENote 5 | |
| Biocompatibility | Compliance withISO10993-5 andISO10993-10 requirements. | Compliance with ISO10993-5and ISO10993-10requirements. | Compliance with ISO10993-5and ISO10993-10requirements. | SE |
| ElectricalSafety | Comply with IEC 60601-1and IEC60601-2-57 | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
1) LED functional modes
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Comparison in Detail(s):
Note 1 (Intended Use):
For LED irradiation modes, we selected K124042 as predicate device to do substantial equivalence discussion for blue light mode of the subject device, while choose K161941 as the second predicate device to do substantial equivalence discussion for the blue and red light mode.
Although there is minor difference for the expressions of intended use between subject device and predicate devices, they all indicated the same indication for use for each working mode, respectively.
Note 2 (Weight, Dimensions, Materials):
These data would be different for different devices because the internal circuit design and components choosing are different. But weight and dimensions won't affect the safety and
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effectiveness of the device since it still belongs to portable device and complied with IEC60601-1. So it would not affect safety and effectiveness of subject device.
Note 3 (LED light Wavelengths):
The LED light wavelengths of the subject device are the same as the predicate device. The wavelengths of blue light mode, comparing between the subject device and K124042, are 415 nm and 414 nm, which are substantially equivalence. The wavelengths of red light, comparing to K161941, are 630 nm, which are substantially equivalence. Therefore, both of blue light wavelength and red light wavelength are the subject device and predict device.
Note 4 (LED light Power Density):
For the LED irradiation mode with red light and blue right, the power density of red light in the subject device is 7.5 mW, but this minor difference of power density would not change lots of LED energy irradiation on the face; and the device pass the testing of IEC60601-2-57, it's safety would not be affected. Therefore, the minor difference of LED power density would not affect the safety and effectiveness of subject device.
Note 5 (Environment for Operating and storage):
These data is to specify the condition of working, transportation and storage. The temperature, RH can be claimed with different condition, and the device pass the testing of IEC60601-1-11. So it can be deemed as the substantially equivalence.
| Elements ofComparison | Subject Device | Remark | Remark |
|---|---|---|---|
| Device Nameand Model | Photon Vibrating massage FacialAesthetic Device, Model: UI-200 | Ultra Renew Plus | -- |
| 510(k) Number | Applying | K132833 | -- |
| Product Code | OLP, ISA | OLP, OHS, ISA | -- |
| Manufacturer | Li-Tek Electronics Technologies | Accord Media | -- |
| Intended Use | The Photon Vibrating massage FacialAesthetic Device (Model: UI-200) isintended for over-the-counter use.LED functional mode- To emit energy in the blue and red region | The Accord Media Ultra Renew Plus isintended to be used:LED functional mode- To emit energy in the red and blue region ofthe spectrum, specifically to treat mild to | SE |
| Elements ofComparison | Subject Device | Remark | Remark |
| of the spectrum, specifically to treat mild to moderate acne on the face.- To emit energy in the blue region of the spectrum to treat mild to moderateinflammatory acne.Vibrating massage functional modeAs an electrically powered device intended for medical purposes to relieve minor aches and pains. | - To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.Ultrasonic functional modeAs an electrically powered device intended for medical purposes to relieve minor aches and pains. | ||
| Basic Unit Characteristics | |||
| PowerSource(s) | 3.7V 1000mAh Li battery | Battery operated | SE |
| Method of LineCurrentIsolation | Type BF Applied Part | Type BF Applied Part | SE |
| Weight | 180g | -- | SENote 1 |
| Dimensions | 3.7" L x 7.6" W x 2.8" D | -- | SENote 1 |
| HousingMaterials andConstruction | Housing made from ABS plastic and output contacts made from stainless steel. | -- | SENote 1 |
| Output Specifications | |||
| VibratingmassageFrequency | 3MHz ± 5% | 3MHz ± 5% | SENote 2 |
| Additional Features | |||
| Environment forOperating | Temperature: 5 ~ 40°CHumidity: ≤ 80% | -- | SENote 3 |
| Environment forStorage | Temperature: 0 ~ 45°CHumidity: ≤ 93% RH | -- | SENote 3 |
| Elements of | Subject Device | Remark | Remark |
| Comparison | |||
| Biocompatibility | All user directly contacting materials arecompliance with ISO10993-5 andISO10993-10 requirements. | All user directly contacting materials arecompliance with ISO10993-5 and ISO10993-10requirements. | SE |
| ElectricalSafety | Comply with IEC 60601-1 andIEC60601-2-57 | Comply with IEC 60601-1 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
2) Vibrating massage functional mode
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Comparison in Detail(s):
Note 1 (Weight, Dimensions, Materials):
These data would be different for different devices because the internal circuit design and components choosing are different. But weight and dimensions won't affect the safety and effectiveness of the device since it still belongs to portable device and complied with IEC60601-1. So it would not affect safety and effectiveness of subject device.
Note 2 (Vibrating massage Frequency):
Both of the ultrasound frequency and the technology principle are the same to the subject device and the predicate device. For the technology principle, the design of both devices is same, and they meant to be pulsed so that therapeutic vibration of the device head at lower frequencies provides massage. Therefore, the subject device and predicate devices are substantially equivalence in Vibrating massage Mode.
Note 3 (Environment for Operating and storage):
These data is to specify the condition of working, transportation and storage. The temperature, RH can be claimed with different condition, and the device pass the testing of IEC60601-1-11. So it can be deemed as the substantially equivalence.
Finial Conclusion:
The subject device " Photon Vibrating massage Facial Aesthetic Device, Model: UI-200" is substantial Equivalence to all predicate devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.