myLEDmask

K223147 · Myblend · OHS · May 14, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K223147
• Device Name: myLEDmask
• Applicant: Myblend
• Product Code: OHS · General, Plastic Surgery
• Decision Date: May 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

myLEDmask is an over-the-counter device that is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

Device Story

myLEDmask is an over-the-counter photobiomodulation device for face and neck wrinkle reduction. It uses 288 LEDs (144 red at 630 nm; 144 near-infrared at 850 nm) to deliver light energy to the skin. The device features a protective eye-shield to prevent ocular exposure. Users select one of three care programs based on skin phototype (fair, moderately dark, or dark), which determines the treatment duration and energy dose. The device is powered by a rechargeable NiMH battery and controlled by an internal microcontroller that manages the timer and automatically shuts off after the session. It is intended for home use by the patient. The healthcare provider does not interact with the device output; the patient uses the device to potentially improve skin appearance by stimulating cell functions via low-power light radiation.

Clinical Evidence

No clinical performance data included. Usability was evaluated with a panel of representative users per FDA guidance. Bench testing only.

Technological Characteristics

Materials: MAKROLON 2805 (mask), silicone (eye cup), Neoprene/Polycotton (band). Principle: Photobiomodulation via 630 nm (red) and 850 nm (NIR) LEDs. Energy: Rechargeable NiMH battery (1.7 Ah). Connectivity: Standalone. Software: Microcontroller-based timer. Standards: IEC 60601-1, 60601-1-2, 60601-2-57.

Indications for Use

Indicated for the treatment of full-face wrinkles in adults using an over-the-counter device.

Regulatory Classification

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.

Predicate Devices

• DPL II PANEL (K171390)
• PRO X OTC 5 Light Therapy device (K140471)
• Biophotas Celluma3 (K171323)
• LG PRA.L DERMA LED MASK (K183671)

Submission Summary (Full Text)

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May 14, 2023

myBlend % José Perez Lead Project Manager Ceiso 69 Rue de Paris Hall B Orsay, 91400 France

Re: K223147

Trade/Device Name: myLEDmask 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: October 5, 2022 Received: October 5, 2022

Dear José Perez:

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Jianting Wang -S

Jianting Wang Acting 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) K223147

Device Name myLEDmask

Indications for Use (Describe)

myLEDmask is an over-the-counter device that is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

| 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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#### K223147

#### PAPIER à ENTETE

#### 510(k) SUMMARY

#### Prepared on 2022-06-06 2023-04-25

## 1. Applicant / Submitter:

| 510(k) Owner | My Blend (SASU) |
|--------------|---------------------------------------------------------------------------------------|
| | 9 Rue du Commandant Pilot, 92200 Neuilly-sur-Seine, France<br>Tel : [phone] |

## 2. Submission correspondent

| Contact Person | Cnnsultant | José PEREZ/ Laetitia ROBIN |
|----------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | CEISO 69 Rue de PARIS, 91400 ORSAY<br>Phone: [phone]<br>Email: [e-mail] / [e-mail] |
| | Manufacturer | Clédia HETTINGER<br>Assistant & Coordinator<br>Phone: [phone]<br>Address: 12 Avenue de la Porte des Ternes 7017 Paris<br>Mail: [e-mail] |
| | Specification Developper/<br>Contract Manufacturer | Hanan BERNARDELLI<br>CEO MOSTLEDS<br>Phone: [phone]<br>Address: 1432 Quai Marcel Dassault 92210 Saint-Cloud France<br>Email Address: [e-mail] |

## 3. Device Name and Code

| Device /trade Name | MyLEDMask |
|--------------------|------------------------------------------------------|
| Classification | 878.4810 |
| Product Code | OHS : light based over the counter wrinkle reduction |
| Panel | General and Plastic Surgery |
| Class | 2 |

#### 4. Predicate devices

| Applicant/Submitter : | LED Technologies Inc | LA LUMIERE, LLC | BioPhotas, Inc.<br>Anaheim, CA 92805<br>USA | LG Electronics, Inc<br>Gyeonggi-do, 17709,<br>Rep. of Korea |
|-----------------------|----------------------|-------------------------------------|---------------------------------------------|-------------------------------------------------------------|
| Device Name : | DPL II PANEL | PRO X OTC 5 Light<br>Therapy device | Biophotas Celluma3 | LG PRA.L DERMA LED<br>MASK |
| Product Code : | OHS | OHS | OHS | OHS |
| 510(k) | K171390 | K140471 | K171323 | K183671 |

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#### 5. Device description

Image /page/4/Picture/2 description: The image shows a white LED face mask. The mask is shaped like a human face and has eye and mouth openings. The mask is attached to a white base with a control panel that has several buttons and the words "myBlend" printed on it. The mask appears to be a beauty device.

MyLEDmask is a device used to perform photobiomodulation (based on lightemitting diode (LED) light) on the face and neck.

Light radiates from the inner surface of the device onto the face and neck. This light is generated by LEDs with two different visible spectrum wavelengths: red (630 nm) and near-infrared (850 nm).

3 Care programs (LEDs activation duration) based on 3 skin phototypes (skin tone) are available.

- Phototype 1 Fair Skin -
-

- Phototype 2 Moderately Dark Skin
- -Phototype 3 Dark Skin

At the end of care duration, device will automatically switch off

It is operated by a microcontroller and powered by rechargeable batteries with an external independent Charger

To prevent irradiation of LED lights to eyes during the treatment, MyLEDmask has protective eye-shield which blocks light energy from LEDs.

### 6. Indications for Use

MyLedMask is an over-the-counter device that is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

### 7. Summary of the technological characteristics

As described in the Product Code "OHS - Light based OTC for wrinkle reduction", MyLEDmask principle of operation is based on generation of Red and Near infrared Light, to interact with skin, in order to reduce wrinkle, as it is long time recognized that application of low-power lights radiation in these wavelength range stimulates and enhances some cell functions.

## 8. Substantial Equivalence/ non-Clinical performance data:

| Property | MyLedMask | DPL II PANEL | PRO X OTC 5 Light<br>Therapy device | Celluma | LG PRA.L DERMA LED<br>MASK |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | Pending | K171390 | K140471 | K171323 | K183671 |
| Manufacturer | MyBlend | LED Technologies Inc. | LA LUMIERE, LLC | BIOPHOTAS Inc. | LG Electronics, Inc. |
| Device Trade<br>name | MyLedMAsk | DPL II PANEL | PRO X OTC 5 Light Therapy<br>device | Celluma | LG PRA.L DERMA LED<br>MASK |
| Class | 2 | | | | |
| Product Code | OHS - Light based OTC for wrinkle reduction | | | | |
| Indications<br>for Use | MyLedMask is an over-the-<br>counter device that is intended<br>to emit energy in the visible<br>and infrared region of the<br>spectrum for use in the<br>treatment of full-face wrinkles | The dp®II Panel System is<br>an Over The Counter<br>(OTC) device intended for<br>use in treating wrinkles. | The Pro X OTC 5 is an Over-<br>The-Counter device<br>intended for use in the<br>treatment of facial wrinkles.<br>It is for people with wrinkles<br>on their face and who have | The BioPhotas Celluma3<br>is intended to emit<br>energy in the visible and<br>infrared region of the<br>spectrum for use in the<br>treatment of full-face<br>wrinkles. | The LG PRA.L DERMA LED<br>MASK is an over-the-<br>counter device that is<br>intended for the use in<br>the treatment of full-face<br>wrinkles. |
| Property | MyLedMask | DPL II PANEL | PRO X OTC 5 Light<br>Therapy device | Celluma | LG PRA.L DERMA LED<br>MASK |
| | | | Fitzpatrick skin types I, II | | |
| | | | and/or III.<br>Calculated at 325 cm² | | |
| Treatment<br>Area (cm2) | About 72 cm² estimated from<br>the LED Mask dimension | 415 cm² | (Overall total Energy 332 J<br>and Total Dose Energy 1.02<br>J/cm²) | Active treatment area of<br>15″ x 8″ (381 mm x 203<br>mm): about 77 cm² | 178.8 x 225 x 89: about<br>50 cm² estimated from<br>the LED Mask dimension |
| Materials | Mask inner face: MAKROLON<br>2805<br>Protective eye cup: Silicon<br>TN750<br>Elastic band holder: Neopren<br>and Polycotton | Not known | Not known | Not known | Mask frame: PC<br>Eye frame: PP<br>Eye shield: Silicone<br>Viewing shield: ABS<br>plastic<br>Controller frame: PP<br>Adaptor frame: PP<br>Cradle frame: PP |
| Dimension<br>(mm) | LED mask: 176 x 342 x 122<br>Storage case: 365 x 225 x 150 | Not known | Not known | Not known | LED Mask: 178.8 x 225 x<br>89<br>Controller: 40 x 30 x 110<br>Adaptor: 87x 44 x 28<br>Cradle: 180 x 229 x 167.8 |
| Net weight<br>(g) | LED mask: 650 g<br>Storage case: 623 g | Not known | Not known | Not known | LED Mask: 225 g /<br>Controller: 84 g<br>Adaptor: 75 g / Cradle:<br>380 g |
| LED Emission | Red: 630 nm (OSRAM LS T67F)<br>NIR: 850 nm (OSRAM SFH 4253) | 605 nm, 630 nm, 660 nm,<br>880 nm | red light (620-630nm)<br>infrared light (855nm) | Red: 640nm+/-25nm<br>NIR: 880nm+/-50nm | RED (637 nm)<br>IR (854 nm) |
| Number of<br>LEDs | Total 288 LEDs<br>- 144 for 630 nm and 144 for<br>850 nm<br>- 244 for the face and 44 for the<br>neck | Not known | Not known | Not known | Total 160 LEDs (80 of<br>them are<br>for 637 nm and the rest<br>80 of<br>them are for 854 nm) |
| LED Power | 18.7 mW/cm²<br>(average of 6 measurement<br>location (including one on the<br>neck) between 10 to 27<br>mW/cm2) | 70.16 mW/cm² | 16 mW/cm² (red)<br>2.9 mW/cm2 (infrared)<br>Total : 18.9 mW/cm² | 6.5 mW/cm² | 25 mW/cm² total |
| Irradiance | According to skin phototype:<br>- 1 fair skin: 6.3 J/cm²<br>- 2 moderately dark skin: 12.5 J<br>/cm²<br>- 3 dark skin: 15.6 J /cm² | 12.6 J/cm²<br>Calculated from Power<br>(70.16 mW/cm2) and<br>Treatment duration 3 min<br>(180 s) | 0.86 J/cm² (red)<br>0.16 J/cm² (infrared)<br>Total : 1.02 J/cm² | 11.7 J/cm² | 13.5 J/cm²<br>Calculated from Power<br>(25 mW/cm²) and<br>Treatment duration 9 min<br>(540 s) |
| Treatment<br>Time | According to skin phototype,<br>daily<br>- 1 fair skin: 5 min 35 (335 s)<br>- 2 moderately dark skin: 11<br>min 10 (670 s)<br>- 3 dark skin: 13 min 55 (835 s)<br>during 6 to 8 weeks | 3 minutes daily<br>5 days per week for 8<br>weeks | 900 seconds per treatment<br>60 times | 3 treatments per week<br>(1800 seconds)- 4 weeks | 9 minutes daily<br>5 days per week for 8<br>weeks |
| Total Energy<br>Dose (J/cm2) | For 8 weeks, 3.5 Treatments<br>(48 h spaced) per week:<br>According to skin phototype:<br>- 1 fair skin: 176 J<br>- 2 moderately dark skin: 350 J<br>- 3 dark skin: 437 J | For 8 weeks, 5<br>Treatments per week :<br>504 J/cm² | For 60 treatments of 900 s :<br>61.2 J/cm² | For 4 weeks, 3<br>Treatments per week :<br>140 J | For 8 weeks, 5<br>Treatments per week :<br>540 J |
| Treatment<br>Control | Device uses a timer and<br>software to control<br>treatment duration.<br>Software Safety Class: A (Low<br>level of concern) | Not known | Not known | Device uses a timer and<br>software to control<br>treatment duration.<br>Software Safety Class: A<br>(Low level of concern) | Not known |
| Battery | NiMH 1.7 Ah | Not known | Not known | Not known | Lithium-ion |
| Power Supply | Voltage: 100 to 240 volts, AC<br>Frequency: 50-60Hz<br>Intensity: 0.35 A | 120-240 V AC | Not known | 110-120V | Input: AC 100V ~ 240V<br>Frequency: 50Hz/60Hz<br>Output: 5V 2A |
| Property | MyLedMask | DPL II PANEL | PRO X OTC 5 Light<br>Therapy device | Celluma | LG PRA.L DERMA LED<br>MASK |
| Electrical<br>Safety | 60601-2-57:2011<br>60601-1:2012<br>60601-1-2:2014 | 60601-1:2006<br>60601-1-2:2007 | 60601-1:2006<br>60601-1-2:2007<br>62471 | 60601-1:2012<br>60601-1-2:2007 | Not known |

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### 9. Summary of the Clinical performance data

No clinical Performance data are included in this submission. However, based on FDA guidance, usability has been evaluated with panel of representative users.

#### Overall Conclusions 10.

Comparison between device described in this 510(k) and predicate devices shows a substantial equivalence based on:

- Same Indications for Use, -
- -Same technological and technical characteristics (Principle of operation)
- -Results of non-clinical tests

Slight differences do not raise any questions regarding safety and effectiveness.

Therefore, it can be concluded that device described in this 510(k) is « as Safe and effective »as the predicate device.