(91 days)
Not Found
No
The device description and performance studies focus on LED light emission and temperature control, with no mention of AI or ML algorithms for analysis, treatment planning, or other functions. The software validation is standard for medical devices and doesn't indicate AI/ML.
Yes
The device is intended for treating wrinkles on the face, which is a therapeutic purpose.
No
The device is intended for treating wrinkles, not for diagnosing any condition.
No
The device description explicitly states it is a "battery powered, hand-held light emitting diode (LED) device" with physical components like an applicator, charging station, and adaptor. It also mentions hardware-related performance testing like "Skin Temperature Testing."
Based on the provided information, the SYNERGY device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "treating wrinkles on the face." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a light-emitting device applied directly to the skin. It does not interact with or analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to sample collection, preparation, or analysis, which are fundamental to IVDs.
Therefore, the SYNERGY is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
Product codes
OHS
Device Description
The SYNERGY is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and infrared spectrum for the treatment of wrinkles on the face. The SYNERGY components include an applicator, a charging station and an adaptor. The treatment surface is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user repairable components. The device is sold for Over the Counter (OTC) use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Entire Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC
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
Non-clinical Testing: The SYNERGY has been tested and conforms to international consensus standards for Electrical safety (ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 and ANSI AAMI IEC 60601-1-2:2014), Additional safety testing (ANSI AAMI IEC60601-1-11 2015, IEC 62471 First edition 2006-07, and IEC 62133-2, Edition1.0 2017-02), and Biocompatibility testing (ISO 10993-5:2009/(R) 2014 and ISO 10993-10 Third Edition 2010-08-01).
Performance testing: Software Validation Testing (The SYNERGY's software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices.") and Skin Temperature Testing (Temperatures of treatment surface were recorded every 1 minute, using a calibrated digital temperature sensor. The test results concluded that the SYNERGY was within specification of 41± 2℃ and did not elevate skin temperature above 43°C.).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
June 29, 2021
YRS Group Inc. % Doris Dong Senior Regulatory Affairs Project Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K210954
Trade/Device Name: Synergy 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: OHS Dated: March 3, 2021 Received: March 30, 2021
Dear Doris Dong:
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.
1
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 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 mediation-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.
Purva Pandya 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
510(k) Number (if known) K210954
Device Name SYNERGY
Indications for Use (Describe)
The SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
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
K210954
510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information 510(k) Number: K210954 Date: June 15th, 2021 Traditional Type of 510(k) Submission: New device Basis for 510(k) Submission: Owner: YRS Group Inc 4480 Delancey Dr Ste 14, Las Vegas, NV, 89103-3753, US Tel: (702) 4268921 Email: usa@opatra.com Doris Dong Contact: [Consultant, from Shanghai CV Technology Co., Ltd.] Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China E-mail: doris.d@ceve.org.cn Tel: 86 21-31261348 / Fax: 86 21-57712250 2. Device Description Proprietary Name: SYNERGY Model: BP-1818R1 Common Name: Red/IR Light Therapy Device Classification Name: Light Based Over The Counter Wrinkle Reduction Regulation Number: 21 CFR 878.4810 OHS Product Code: Device Class: II Review Panel: General & Plastic Surgery The SYNERGY is an over-the-counter, battery powered, hand-held light Device Description: emitting diode (LED) device that emits light energy in the red and infrared spectrum for the treatment of wrinkles on the face. The SYNERGY components include an applicator, a charging station and an adaptor. The treatment surface is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user repairable components. The device is sold for Over the Counter (OTC) use. Indications for use: The SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
3. Substantial Equivalence to Predicate device
Detailed comparison data is included in "Section 10 - Substantial Equivalence Discussion" of this 510(k) submission.
Table 1-
| Parameters | New Device | Predicate Device | Remark |
|---|---|---|---|
| 510(k) number | K210954 | K172909 | -- |
| Device name | SYNERGY | Elevare Plus | -- |
| Product code | OHS | OHS | Same |
4
| Class | II | II | Same |
|---|---|---|---|
| Indication for use | The SYNERGY is an | ||
| Over-the-Counter (OTC) device | |||
| intended for the use in treating | |||
| wrinkles on the face. | The Elevare Plus is an | ||
| Over-the-Counter (OTC) device | |||
| intended for the use in treating | |||
| wrinkles on the face. | Same | ||
| Anatomical site | Entire Face | Entire Face | Same |
| Handheld | Yes | Yes | Same |
| wavelengths | 610, 630, 660, 850nm ±5nm | 610, 630, 660, 850nm ±5nm | Same |
| Irradiance source | LED | LED | Same |
| Visible light LEDs | Yes | Yes | Same |
| LED Array | 16 LEDs, Over 17cm² | 25 LEDs, Over 17cm² | Similar |
| Note 1 | |||
| Energy Level | |||
| (mW/cm²) | 65 mW/cm² (± 5 mW/cm²) | 65 mW/cm² (± 5 mW/cm²) | Same |
| Power Supply | Li-Ion rechargeable batteries | Li-Ion rechargeable batteries | Same |
| Treatment Time | 3 minutes each area each mode, 5 | ||
| days per week for 8 weeks | 3 minutes daily, 5 days per week | ||
| for 8 weeks | Similar | ||
| Note 2 | |||
| Target population | Individuals with wrinkles on the | ||
| face | Individuals with wrinkles on the | ||
| face | Same | ||
| Location for use | OTC | OTC | Same |
| Main material | ABS and stainless steel | ABS and stainless steel | Same |
Summary of the technological characteristics of the device compared:
Note 1:
The subject device is slightly different from the predicate device in terms of LEDs and appearance. The subject device has 16 LEDs while the predicate device has 25 LEDs,but they have the same energy density, and both of them have passed the tests of IEC 60601-1 and IEC 62471, these differences will not raise any new issues of safety or effectiveness.
Note 2:
The treatment time of the proposed device is slightly different from the predicate device uses 4 wavelengths of LEDs to work simultaneously for 3 minutes, while the proposed device sets 4 wavelengths in two modes (Mode 1: 610nm & 630nm, Mode 2: 660nm & 850nm), each mode is treated for 3 minutes. Considering both of them have the same treatment time of each wavelength, the energy produced by these wavelengths, power density and maintenance time are also the same, it can be concluded that the same treatment effect as the predicate device can be achieved. In addition, the proposed device has passed the tests of IEC 60601-1 and IEC 62471. Based on above analysis, these differences will not cause any safety and effectiveness issues.
4. Non-clinical Testing
The conclusions drawn from the non-clinical testing below demonstrate that the SYNERGY is substantially equivalent to the predicate devices K172909. The SYNERGY has been tested and conforms to international consensus standards:
Electrical safety:
- ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 ● (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
EMC:
5
K210954
-
ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --Requirements And Tests;
Additional safety testing: -
ANSI AAMI IEC60601-1-11 2015 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment;
-
IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems; ●
-
IEC 62133-2, Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems;
Biocompatibility testing:
- ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
The SYNERGY has been tested to ensure the device meets specifications:
Performance testing
-
Software Validation Testing ●
The SYNERGY's software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." -
Skin Temperature Testing
Temperatures of treatment surface were recorded every 1 minutes, using a calibrated digital temperature sensor. The test results concluded that the SYNERGY was within specification of 41± 2℃ and did not elevate skin temperature above 43°C.
5. Conclusions
Based upon comparison to the predicate devices, the SYNERGY has the same intended uses, with similar technological characteristics as predicate device SYNERGY is substantially equivalent to the predicate device K172909.