(193 days)
K202055- Looper (Model: ZX-579S)- Heat In A Click LLC
K190443- MMSphere™ - Galactic Beauty, LLC
No
The document describes a simple LED light therapy device with no mention of AI or ML capabilities.
Yes
The device is intended for treating wrinkles and mild to moderate inflammatory acne, which are therapeutic claims addressing medical conditions.
No
The device is described as being for "aesthetic purposes" and "treating wrinkles" and "mild to moderate inflammatory acne." These are therapeutic, not diagnostic, uses.
No
The device description explicitly states it is a "hand-held light emitting diode (LED) device" with physical components like an applicator, charging station, and adaptor. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This includes tests for diagnosing, monitoring, or screening for diseases or conditions.
- SYNERGY MARBLE's Function: The SYNERGY MARBLE is a light-emitting device that applies light energy directly to the skin for aesthetic and therapeutic purposes (treating wrinkles and acne). It does not analyze any biological samples taken from the body.
The description clearly states its intended use is for direct application to the skin for treatment, not for analyzing samples in a lab setting.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
The SYNERGY MARBLE is an over-the-counter, battery powered hand-held light emitting diode (LED) device that emits light energy in th 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).
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
Over the Counter
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)
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.
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.
K202055- Looper (Model: ZX-579S)- Heat In A Click LLC
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.
K190443- MMSphere™ - Galactic Beauty, LLC
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
§ 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.
0
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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.
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.
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 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 powered |
| hand-held light emitting diode (LED) device that emits light energy in th | |
| 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). | |
| 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. |
3. Substantial Equivalence Devices Identification
| Predicate Device: | K202055- Looper (Model: ZX-579S)- Heat In A Click LLC |
|---|---|
| Reference Device: | K190443- MMSphere™ - Galactic Beauty, LLC |
4
| 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 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. | Looper (Model: ZX-579S) is a hand-held | |||
| device for over-the counter aesthetic | ||||
| purposes. The Photon mode red light is | ||||
| 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. | MMSphereTM Light Therapy Device emits | |||
| energy in the red, blue and amber regions of | ||||
| the spectrum, specifically indicated to treat | ||||
| wrinkles and/or mild to moderate acne. The | ||||
| MMSphereTM is designed to be used for 20 | ||||
| minute treatments three to seven times per | ||||
| week. | 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 to | |||
| moderate acne on the face | Individuals with wrinkles and/or mild to | |||
| moderate acne on the face | Individuals with wrinkles and/or mild to | |||
| moderate 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 and | ||||
| Wavelengths | Mode 1: Red (625nm±3nm) | |||
| Mode 2: Blue (465nm±3nm) | ||||
| Mode 3: Amber (605nm±3nm) | SONIC Mode: 5 intensity levels | |||
| PHOTON Mode (two modes): | ||||
| Red: 630nm±10nm | ||||
| Blue: 415±10nm | Red: 625nm | |||
| Blue: 465nm | ||||
| Amber: 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/cm² | ||
| Amber:Not publicly available | ||||
| Treatment Time | 3 minutes per target area; 2 treatments per | |||
| week for 6 weeks | 3 minutes per target area; 2 treatments per | |||
| week 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 |
5
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.