Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a light therapy device using LEDs and different light spectrums for treatment. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device description or performance studies.

Therapeutic

Yes
The device is indicated to treat wrinkles and/or mild to moderate acne, which are medical conditions, and it uses light therapy technology for this purpose.

Diagnostic

No

The device is indicated to treat wrinkles and/or mild to moderate acne, which are therapeutic uses, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Light Therapy Device using LED light therapy technology" and mentions physical components like "LED light therapy technology," "red light (625nm), blue light (465nm), and amber (605nm)," "provided goggles," and the ability to be used "handheld" or "placed on a countertop." These are all hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, 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, tissue) to provide information for diagnosis, monitoring, or screening.
MMSphere™ Function: The MMSphere™ is a light therapy device that applies light directly to the skin for the treatment of wrinkles and acne. It does not analyze any biological specimens.

The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

OHS, OLP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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)

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.

ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ANSI/AAMI ES 60601-1:2005+A2 (R2012) +A1: Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2015: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6:2010+A1: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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
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
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
IEC 62471:2006: Photobiological safety of lamps and lamp systems

Non-Clinical Testing: 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:

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 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.

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.

K120775, K180847, K180856

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

1

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)
-------------------------------------------------

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, LLC
Attn: Ellen Marmur, MD
12 E 87 ST STE 1A
New York, New York 10128
Tel: 212-996-6900
emarmur@gmail.com |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Specification Developer | Galactic Beauty, LLC
Attn: Ellen Marmur, MD
12 E 87 ST STE 1A
New York, New York 10128
Tel: 212-996-6900
emarmur@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

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.

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 Light
Therapy Acne
Mask | Neutrogena Light
Therapy Aging
Mask | LightStim For
Wrinkles |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| 510K Number | K190443 | K180847 | K180856 | K120775 |
| Product Code | OHS, OLP | OLP | OHS | OHS |
| Classification
Name | OTC Powered
Light for
Wrinkle
Reduction and
Acne | Over the Counter
powered Light
Based Laser for
Acne | Light-based
over-the-counter
wrinkle reduction | Light-based
over-the-counter
wrinkle reduction |
| Regulatory Class | Class II | | | |
| Classification
Regulation | 21 CFR 878.4810 | | | |
| Classification
Panel | General and Plastic Surgery | | | |
| Indications for
Use | OTC Light
Therapy Device
using LED light
for the
treatment of
wrinkles and
mild to
moderate acne. | The Light
Therapy Acne
Mask + is
intended to emit
energy in the red
and blue region
of the
spectrum,
specifically
indicated to treat
mild to moderate
acne on the face. | The Neutrogena
Light Therapy
Aging
Mask+ is an over
the
counter device
that is
indicated for the
treatment of full
face
wrinkles. | The Light for
Wrinkles is an
Over-The-Counter
handheld device
intended for use in
the treatment of
full-face wrinkles. |
| Handheld or
stationary | Both | Mask | Mask | Handheld |
| Irradiance Source | LEDs | LEDs | LEDs | LEDs |
| Light Color and
Wavelengths | 605nm
625nm
465nm | Red 630nm±5nm
Blue 440nm±5nm | Red 620-640nm
IR 820-880nm | 605nm,
630nm,
660nm,
855nm |
| Total Energy
Dose J/cm² * | Blue- 24.48
Red- 44 | 38.38 | 47.58 | 25.92 |
| Power Density | Red 2.45
mW/cm²
Blue 1.33
mW/cm² | 1.07 mW/cm² | 1.32 mW/cm² | 2.4 mW/cm² |
| Treatment
Regimen | 20mins/day,
120 days | 10mins/day, 60
days | 10mins/day, 60
days | 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