MMSphere™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 MMSphere™is designed to be used for 20 minute treatments three to seven times per week.

Device Description

MMSphere™is an OTC, multi-use Light Therapy Device using LED light therapy technology for the treatment of mild to moderate wrinkles and/or acne. The device uses a combination of red light (625nm), blue light (465nm), and amber (605nm) to create different treatment settings. The user will wear provided goggles for treatments. Device can be used with handheld option or placed on a countertop.

AI/ML Overview

The provided document is a 510(k) summary for the MMSphere™ Light Therapy System. It details the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain information about clinical studies with human subjects or a detailed breakdown of acceptance criteria and performance results in the format requested.

The document primarily focuses on:

Bench performance testing: Demonstrating safety and effectiveness through compliance with consensus standards (ISO, ANSI/AAMI, IEC) for electrical safety, EMC, photobiological safety, and battery safety.
Usability Testing: Assessing the ease of use with 35 subjects.

Therefore, many of the requested items regarding acceptance criteria, human study design, expert ground truth, and statistical results cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Information in document: The document mentions compliance with several technical standards (e.g., IEC 60601 electrical safety, IEC 60601 EMC, IEC 62471 photobiological safety). The "acceptance criteria" for these would be successful adherence to the requirements of these standards.
Reported performance: The document states, "This device is in conformity with IEC 60601 electrical safety testing, IEC 60601 EMC testing and IEC 62471 photobiological safety testing." This is the reported performance – a statement of conformity, not specific numerical results against acceptance criteria.
Detailed Table: A table with specific, quantifiable acceptance criteria and performance data for clinical efficacy (e.g., wrinkle reduction percentage, acne clearance rate) is not provided. The document states the device treats wrinkles and mild to moderate acne, but does not provide clinical data to demonstrate specific performance against these indications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Information in document: For the Usability Study, 35 subjects were used.
Data Provenance: Not specified for the usability study (country, retrospective/prospective).
Missing: There is no clinical test set mentioned for efficacy assessment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing: This information pertains to clinical study ground truth establishment, which is not described in this 510(k) summary. The "experts" mentioned are primarily the submitter (Ellen Marmur, MD) and the FDA in their review process, but not in the context of establishing ground truth for a clinical efficacy test dataset.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing: Not applicable as there is no described clinical efficacy test set with adjudicated ground truth.

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

Missing: This is a laser/light therapy device, not an AI-powered diagnostic or assistive tool for human "readers" (e.g., radiologists). Therefore, an MRMC study is not relevant here and was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing: Not applicable, as this is a physical device for direct application, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing: For clinical efficacy, the type of ground truth used is not described because no clinical efficacy study is detailed. For the usability study, the "ground truth" was the subjects' responses to a survey about ease of use.

8. The sample size for the training set

Missing: No "training set" is mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Missing: Not applicable, as no training set is mentioned.

Summary of Device Performance based on provided document:

The MMSphere™ Light Therapy System's "performance" in this 510(k) summary is demonstrated through:

Bench Performance Testing: Asserted conformity with various international standards for electrical safety (IEC 60601-1), electromagnetic compatibility (EN 60601-1-2), photobiological safety (IEC 62471), and battery safety (IEC 62133-2). The document states conformity but does not provide specific data or acceptance limits for this.
Usability Testing:
- Sample Size: 35 subjects.
- Methodology: Subjects were asked to turn the device on/off, change settings, demonstrate recharging, and complete a 10-question usability survey.
- Findings/Improvements: Two specific concerns were identified:
  - Tightness of the ON/OFF/settings knob.
  - Recessed and not easily identifiable/accessible charging port.
- Acceptance Criteria for Usability (Implied): While not explicitly stated, the goal was likely to identify usability issues that could be addressed. The document indicates these findings were addressed, suggesting the "acceptance" was that the device met a preliminary usability standard, or that identified issues were remediated.

Conclusion from document: The manufacturer asserts "no significant differences exist between the new device and the predicate devices and no new issues of safety or effectiveness are raised," leading to the conclusion of substantial equivalence. This statement serves as the overall "acceptance" in the context of a 510(k) submission, rather than meeting specific quantifiable performance metrics from a clinical study within this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Galactic Beauty, LLC Ellen Marmur President/CEO 12 E 87 St., Ste 1A New York, New York 10128

June 24, 2019

Re: K190443

Trade/Device Name: MMSphere 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: Mav 28, 2019 Received: May 29, 2019

Dear Ellen Marmur:

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.

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

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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.

Neil R.P. Ogden, MS Acting Assistant Director, THT4A3 DHT4A: Division of General Surgery Devices OHT5: 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)

Device Name

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary MMSphere™ Light Therapy System

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR § 878.4810.

Submission Date: February 22, 2018

Submitter Information	Galactic Beauty, LLCAttn: Ellen Marmur, MD12 E 87 ST STE 1ANew York, New York 10128Tel: 212-996-6900emarmur@gmail.com
Specification Developer	Galactic Beauty, LLCAttn: Ellen Marmur, MD12 E 87 ST STE 1ANew York, New York 10128Tel: 212-996-6900emarmur@gmail.com

2. General Information

Classification Name: Light Based Over The Counter Acne and Wrinkle Reduction 2.1
Common/Usual Name: Acne and Wrinkle Light Therapy System 2.2
Proprietary Names: MMSphere™ 2.3
2.4 Classification: Class II
2.5 Classification Number: 878.4810
2.6 Product Code: OHS/OLP
Review Panel: General & Plastic Surgery 2.7

3. Device Description

MMSphere™is an OTC, multi-use Light Therapy Device using LED light therapy technology for

the treatment of mild to moderate wrinkles and/or acne.

The device uses a combination of red light (625nm), blue light (465nm), and amber (605nm) to create different treatment settings.

The user will wear provided goggles for treatments. Device can be used with handheld option or placed on a countertop. See Appendix: 11-1-Device Drawing and 11-3 System Level Schematic

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4. Indications for Use

5. Predicate Device

This device is substantially equivalent to the following predicates, which are currently cleared under product codes OHS/OLP:

1. K120775 LightStim For Wrinkles
1. K180847 Neutrogena Light Therapy Acne Mask+
1. K180856 Neutrogena Light Therapy Aging Mask+

6. Comparison of Technological Characteristics with The Predicate Device

LightStim For Wrinkles K120775, Neutrogena Light Therapy Acne Mask K180847 and Neutrogena Light Therapy Aging Mask K180856 to the MMSphere™ Light Therapy System with respect to intended use, technological characteristics, principles of operation and performance data.

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Device Comparison Table

	MMSphere™	Neutrogena LightTherapy AcneMask	Neutrogena LightTherapy AgingMask	LightStim ForWrinkles
510K Number	K190443	K180847	K180856	K120775
Product Code	OHS, OLP	OLP	OHS	OHS
ClassificationName	OTC PoweredLight forWrinkleReduction andAcne	Over the Counterpowered LightBased Laser forAcne	Light-basedover-the-counterwrinkle reduction	Light-basedover-the-counterwrinkle reduction
Regulatory Class	Class II
ClassificationRegulation	21 CFR 878.4810
ClassificationPanel	General and Plastic Surgery
Indications forUse	OTC LightTherapy Deviceusing LED lightfor thetreatment ofwrinkles andmild tomoderate acne.	The LightTherapy AcneMask + isintended to emitenergy in the redand blue regionof thespectrum,specificallyindicated to treatmild to moderateacne on the face.	The NeutrogenaLight TherapyAgingMask+ is an overthecounter devicethat isindicated for thetreatment of fullfacewrinkles.	The Light forWrinkles is anOver-The-Counterhandheld deviceintended for use inthe treatment offull-face wrinkles.
Handheld orstationary	Both	Mask	Mask	Handheld
Irradiance Source	LEDs	LEDs	LEDs	LEDs
Light Color andWavelengths	605nm625nm465nm	Red 630nm±5nmBlue 440nm±5nm	Red 620-640nmIR 820-880nm	605nm,630nm,660nm,855nm
Total EnergyDose J/cm² *	Blue- 24.48Red- 44	38.38	47.58	25.92
Power Density	Red 2.45mW/cm²Blue 1.33mW/cm²	1.07 mW/cm²	1.32 mW/cm²	2.4 mW/cm²
TreatmentRegimen	20mins/day,120 days	10mins/day, 60days	10mins/day, 60days	3mins/day, 60days

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Conclusion

After an analysis of the safety indications, intended uses, performance, design materials, power output, technological characteristics, treatment areas, and treatment regimes, the Sponsor believes that no significant differences exist between the new device and the predicate devices and no new issues of safety or effectiveness are raised. Therefore substantial equivalency has been demonstrated.

7. Performance Testing

Bench performance testing was undertaken to demonstrate that the MMSphere™is safe and effective and substantially equivalent to the predicate devices. The following are applicable consensus standards.

1. ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
1. ANSI/AAMI ES 60601-1:2005+A2 (R2012) +A1: Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
1. EN 60601-1-2:2015: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
1. IEC 60601-1-6:2010+A1: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
1. IEC 60601-1-11:2015: Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
1. IEC 60601-2-57:2011: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
1. IEC 62133-2:2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
1. IEC 62471:2006: Photobiological safety of lamps and lamp systems

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Non-Clinical Testing 8.

This device is in conformity with IEC 60601 electrical safety testing, IEC 60601 EMC testing and IEC 62471 photobiological safety testing.

Usability Testing

35 subjects identified with wrinkles and/or acne were given the device, the user manual and a charging cable. They were asked to turn the device on and off, change the device settings, and demonstrate how to recharge the device. After this exercise, they were asked to complete a usability survey list of 10 questions indicating how easy it was to follow instructions and use the device.

Out of 35 users participating in the Usability Study:

Addressing Usability Findings

During the course of administering the Usability Test, two specific concerns were discovered:

. The design of the knob that controls the ON and OFF positions as well as the light settings were found to be too tight to turn comfortably by the operator.
The second concern was discovered when the operators were asked to charge . the device. The access port to plug in the charging cable on the base of the device was found to be too recessed and not easily identifiable or accessible.

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9. Substantial Equivalence

Based upon the analysis of the overall performance characteristics the MMSphere™ device has the same intended use as the predicate devices. The device also has similar technological characteristics to the predicate devices. The differences between the devices do not pose any safety risks to the user.

We have shown by the data contained in this 510(k) submission that the Sponsor has found no significant differences between the MMSphere™ and the predicate devices

Regulation Number and Section

§ 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.