(492 days)
Not Found
No
The device description and performance studies focus on LED light therapy and vibrating massage, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment adjustment.
Yes
The device is intended for medical purposes, specifically to treat mild to moderate acne and relieve minor aches and pains, which aligns with the definition of a therapeutic device.
No
The device is intended for treatment (acne, aches, and pains) rather than for diagnosing any conditions.
No
The device description clearly states it is a physical device with hardware components (LEDs, vibrating mechanism, internal battery, charging port, stainless steel contactor). The software mentioned is for controlling these hardware functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a facial aesthetic device that uses LED light and vibration applied directly to the skin. Its intended uses are treating acne and relieving minor aches and pains.
- The description and intended use clearly indicate a direct interaction with the body's surface, not the analysis of internal specimens.
Therefore, the Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) falls under the category of a therapeutic or aesthetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OLP, ISA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter use / 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)
- Electrical safety test according to IEC 60601-1 Edition 3.0: 2005+A1:2012 and IEC60601-2-57 Edition 1.0: 2011
- 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.
- 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.
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
Not Found
§ 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.
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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
2
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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3
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, Model
UI-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 |
4
- 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 Skincare | |
| System | Pulsaderm Acne | ||
| Device | |||
| 510(k) Number | K132833 | K124042 | K161941 |
| Product Code | OLP, OHS, ISA | OLP | OLP |
| Regulation | |||
| Number | 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
5
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.
6
| Device Requiring
Biocompatibility | Component | Category
(ISO 10993-1) | (ISO 10993-1) |
|------------------------------------------------------------|-----------------|------------------------------------|--------------------------------|
| stainless steel
treatment head for
vibrating massage | Stainless steel | Surface-contacting
device: skin | Maximum 2 hours
(