(193 days)
SYNERGY MARBLE is a hand-held device for over-the counter aesthetic purposes. The device red light and amber light are intended for the use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
The SYNERGY MARBLE is an over-the-counter, battery powered hand-held light emitting diode (LED) device that emits light energy in the red, blue and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The SYNERGY MARBLE 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 as Over the Counter (OTC).
The provided 510(k) summary for the SYNERGY MARBLE (Model: Opasm) device does NOT include a robust clinical study or performance-based acceptance criteria for its intended uses (treating wrinkles and mild to moderate inflammatory acne).
Instead, the submission relies on non-clinical testing and a demonstration of substantial equivalence to previously cleared predicate devices. Therefore, a table of acceptance criteria and reported device performance with associated study details cannot be fully constructed as requested.
However, based on the information provided, we can infer some "acceptance criteria" through the lens of substantial equivalence and present the non-clinical testing conducted.
Inferred Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Non-Clinical Testing)
| Acceptance Criteria (Inferred from Predicate & Standards) | Reported Device Performance (SYNERGY MARBLE) |
|---|---|
| Safety: | |
| Electrical Safety (IEC 60601-1) | Conforms to ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009(R)2012, and A2:2010(R)2012 (Consolidated Text) |
| Electromagnetic Compatibility (IEC 60601-1-2) | Conforms to IEC 60601-1-2 Edition 4.0 2014-02 |
| Usability (IEC 60601-1-6) | Conforms to IEC 60601-1-6 Edition 3.1 2013-10 |
| Home Healthcare Environment (IEC 60601-1-11) | Conforms to IEC 60601-1-11 Edition 2.0 2015-01 |
| Photobiological Safety (IEC 62471) | Conforms to IEC 62471 First edition 2006-07 |
| Battery Safety (IEC 62133-2) | Conforms to IEC 62133-2, Edition1.0 2017-02 |
| Biocompatibility: | |
| In Vitro Cytotoxicity (ISO 10993-5) | Conforms to ISO 10993-5:2009/(R) 2014 |
| Irritation and Skin Sensitization (ISO 10993-10) | Conforms to ISO 10993-10 Third Edition 2010-08-01 |
| Systemic Toxicity (ISO 10993-11) | Conforms to ISO 10993-11 Third edition 2017-09 |
| Performance (Inferred from Substantial Equivalence): | |
| Indications for Use | "SYNERGY MARBLE is a hand-held device for over-the counter aesthetic purposes. The device red light and amber light are intended for the use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne." |
| Power and Wavelengths | Red (625nm±3nm), Blue (465nm±3nm), Amber (605nm±3nm) |
| Energy Density | Red: 55.3mW/cm²±10%Blue: 48.2mW/cm²±10%Amber: 38.3mW/cm²±10% |
| Treatment Time | 3 minutes per target area; 2 treatments per week for 6 weeks |
| Product Code | OHS, OLP (Same as predicates) |
| Regulation Number | 21 CFR 878.4810 (Same as predicates) |
| Device Class | II (Same as predicates) |
Study Details (Based on the provided 510(k) Summary)
The provided document describes non-clinical testing for safety and performance related to electrical safety, EMC, usability, photobiological safety, battery safety, and biocompatibility. It does NOT describe a clinical study to directly prove the device meets acceptance criteria for its intended therapeutic effects (treating wrinkles or acne).
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The document refers to non-clinical bench testing and conformity to international consensus standards, rather than a test set of patient data.
- Data Provenance: The data provenance is from laboratory bench testing (non-clinical) and conformity assessments against international standards. No specific country of origin is mentioned for these lab tests, but the manufacturer is YRS Group Inc. (US) and the consultant is from Shanghai, China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this was non-clinical testing against established standards, there was no "ground truth" established by experts in a clinical context. Results were compared against the requirements of the standards themselves.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring adjudication.
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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:
- No MRMC comparative effectiveness study was done. This device is a light-based therapy device, not an AI-assisted diagnostic or therapeutic device requiring human reader assessment.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a direct-use therapy device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" was defined by the specific requirements and limits set forth in the international consensus standards (e.g., maximum current leakage for electrical safety, specific wavelengths and energy densities, cytotoxicity limits). There was no clinical ground truth established for effectiveness.
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The sample size for the training set:
- Not applicable. This review concerns non-clinical testing and substantial equivalence, not a machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
Conclusion from document:
The SYNERGY MARBLE device gained clearance by demonstrating substantial equivalence to existing legally marketed predicate devices (K202055 - Looper and K190443 - MMSphere™) through a comparison of technological characteristics and intended uses, alongside conformity to relevant non-clinical safety (electrical, EMC, photobiological, battery, usability, home use) and biocompatibility standards. The submission explicitly states: "The conclusion drawn from the non-clinical tests is that the device is as safe, as effective, and performs as well as the legally marketed predicate device K202055 and reference device K190443." This implies that clinical effectiveness for wrinkle reduction and acne treatment is primarily supported by the established effectiveness of the predicate devices, rather than a new clinical study.
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July 22, 2022
YRS Group Inc % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K220064
Trade/Device Name: Synergy Marble (Model: Opasm) 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, OLP Dated: June 27, 2022 Received: July 5, 2022
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.
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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.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220064
Device Name SYNERGY MARBLE
Indications for Use (Describe)
SYNERGY MARBLE is a hand-held device for over-the counter aesthetic purposes. The device red light and amber light are intended for the use in treating wrinkles on the blue light is intended for the treatment of the mild to moderate inflammatory acne.
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 [As required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K220064 |
|---|---|
| Date: | July 21, 2022 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Owner: | YRS Group Inc. |
| 5151 S Procyon St, Suite 105, Las Vegas, NV 89118, US | |
| Tel: 1-702 4268921 | |
| Email: usa@opatra.com | |
| Contact: | Doris Dong[Consultant, from Shanghai CV Technology Co., Ltd.]Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 ChinaE-mail: doris.d@ceve.org.cnTel: 86 21-31261348 / Fax: 86 21-57712250 |
| 2. Device Description | |
| Proprietary Name: | SYNERGY MARBLE |
| Model: | OPASM |
| Classification Name: | Light Based Over The Counter Wrinkle Reduction (OHS)Over-The-Counter Powered Light Based Laser For Acne (OLP) |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | OHS, OLP |
| Device Class: | II |
| Review Panel: | General & Plastic Surgery |
| Device Description: | The SYNERGY MARBLE is an over-the-counter, battery poweredhand-held light emitting diode (LED) device that emits light energy in thred, blue and amber spectrum for the treatment of wrinkles or mild tomoderate inflammatory acne on the face. The SYNERGY MARBLEcomponents include an applicator, a charging station and an adaptor.The treatment surface is applied directly to the skin to ensure consistentadministration of light during each treatment. The device does not containany user repairable components. The device is sold as Over the Counter(OTC). |
| Indications for use: | SYNERGY MARBLE is a hand-held device for over-the counter aestheticpurposes. The device red light and amber light are intended for the use intreating wrinkles on the face, and the blue light is intended for the treatmentof the mild to moderate inflammatory acne. |
3. Substantial Equivalence Devices Identification
| Predicate Device: | K202055- Looper (Model: ZX-579S)- Heat In A Click LLC |
|---|---|
| Reference Device: | K190443- MMSphere™ - Galactic Beauty, LLC |
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| 4. Substantial Equivalence to Predicate device | |
|---|---|
| ------------------------------------------------ | -- |
| Parameters | New Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 510(k) number | K220064 | K202055 | K190443 | -- |
| Device name | SYNERGY MARBLE | Looper | MMSphereTM | -- |
| Model | OPASM | ZX-579S | / | -- |
| Owner | YRS GROUP INC | Heat In A Click LLC | Galactic Beauty, LLC | -- |
| Product code | OHS, OLP | OHS, OLP | OHS, OLP | Same |
| Class | II | II | II | Same |
| Indication for use | SYNERGY MARBLE is a hand-held devicefor over-the counter aesthetic purposes. Thedevice red light and amber light are intendedfor the use in treating wrinkles on the face,and the blue light is intended for the treatmentof the mild to moderate inflammatory acne. | Looper (Model: ZX-579S) is a hand-helddevice for over-the counter aestheticpurposes. The Photon mode red light isintended for the use in treating wrinkles onthe face, and the blue light is intended for thetreatment of the mild to moderateinflammatory acne. | MMSphereTM Light Therapy Device emitsenergy in the red, blue and amber regions ofthe spectrum, specifically indicated to treatwrinkles and/or mild to moderate acne. TheMMSphereTM is designed to be used for 20minute treatments three to seven times perweek. | Similar |
| Use | Over the Counter | Over the Counter | Over the Counter | Same |
| Anatomical site | Entire Face | Entire Face | Entire Face | Same |
| Type | Hand-held | Hand-held | Handheld and stationary | Same |
| Target Population | Individuals with wrinkles and/or mild tomoderate acne on the face | Individuals with wrinkles and/or mild tomoderate acne on the face | Individuals with wrinkles and/or mild tomoderate acne on the face | Same |
| Irradiance source | LED | LED | LED | Same |
| Visible light LEDs | Yes | Yes | Yes | Same |
| LED Array | 8 LEDs, Over 17cm² | 22 LEDs over 12±10%cm² | Not publicly available | Similar |
| Working Modes andWavelengths | Mode 1: Red (625nm±3nm)Mode 2: Blue (465nm±3nm)Mode 3: Amber (605nm±3nm) | SONIC Mode: 5 intensity levelsPHOTON Mode (two modes):Red: 630nm±10nmBlue: 415±10nm | Red: 625nmBlue: 465nmAmber: 605nm | Similar |
| Energy density | Red: 55.3mW/cm²±10% | Red: 55mW/cm²±10% | Red: 2.45mW/cm² | Similar |
| Blue: 48.2mW/cm²±10%Amber:38.3mW/cm²±10% | Blue: 48mW/cm²±10% | Blue: 1.33mW/cm²Amber:Not publicly available | ||
| Treatment Time | 3 minutes per target area; 2 treatments perweek for 6 weeks | 3 minutes per target area; 2 treatments perweek for 6 weeks | 20 minutes/day, 120days | Same |
| Power Supply | Lithium battery | Lithium battery | Lithium battery | Same |
| Main material | ABS | ABS Plastic & Stainless Steel | Not publicly available | Similar |
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5. Non-clinical Testing
The SYNERGY MARBLE has been evaluated the safety and performance by lab bench testing and conforms to the following international concensus standards: Electrical safety:
- ANSI AAM ES66601-1: 2005/R)2012 And A1:2012, C1:2009(R)2012 And A.22010(R)2012 (Consolidated Text) Medical Electrical Equipment Patt 1: General . Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
EMC:
- . IEC 60601-1-2 Edition 4.0 2014-02, Medical equipment - Part 1-2: General requirements for base safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests;
Additional safety testing:
- IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equirements for basic satety and essential performance Collateral standard: Usbility; ●
- IEC 60601-1-11 Edition 2.0 2015-01 Medical equipment Part 1-11: General requirements for basic and essential performace Collated Standard: ● Requirements for 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 electroytes 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. ●
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And Skin Sensitization. ●
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
6. Conclusions
The conclusion drawn from the non-chnical tests dence is as safe, as safe, as effective, and performs as well as the legally marketed predicate device K20205 and reference device K190443.
§ 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.