(221 days)
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.
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.
The provided text is a 510(k) premarket notification for a medical device called "myLEDmask." This document is used by the FDA to determine if a new device is "substantially equivalent" to an already legally marketed device (predicate device).
Based on the information provided, the "myLEDmask" does not rely on clinical performance data for its clearance. The document explicitly states:
"No clinical Performance data are included in this submission. However, based on FDA guidance, usability has been evaluated with panel of representative users." (Page 6, Section 9)
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information cannot be extracted from this document, as a clinical performance study was not performed or submitted for this 510(k) clearance.
The clearance is based on:
- Substantial Equivalence: The device is considered substantially equivalent to predicate devices based on:
- Same Indications for Use.
- Same technological and technical characteristics (Principle of operation).
- Results of non-clinical tests.
The document highlights the device's technical specifications and compares them to several predicate devices. This comparison serves as the basis for demonstrating substantial equivalence rather than a new clinical study.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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, FranceTel : +33 1 56 60 65 35 |
2. Submission correspondent
| Contact Person | Cnnsultant | José PEREZ/ Laetitia ROBIN |
|---|---|---|
| CEISO 69 Rue de PARIS, 91400 ORSAYPhone: +33 6 27 30 01 94 / +33 6 42 19 30 64Email: jose.perez@ceiso.fr / laetitia.robin@ceiso.fr | ||
| Manufacturer | Clédia HETTINGERAssistant & CoordinatorPhone: +33 6 89 08 11 79Address: 12 Avenue de la Porte des Ternes 7017 ParisMail: cledia.hettinger@clarins.com | |
| Specification Developper/Contract Manufacturer | Hanan BERNARDELLICEO MOSTLEDSPhone: +33 6 85 14 26 08Address: 1432 Quai Marcel Dassault 92210 Saint-Cloud FranceEmail Address: hanan@mostleds.com |
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.Anaheim, CA 92805USA | LG Electronics, IncGyeonggi-do, 17709,Rep. of Korea |
|---|---|---|---|---|
| Device Name : | DPL II PANEL | PRO X OTC 5 LightTherapy device | Biophotas Celluma3 | LG PRA.L DERMA LEDMASK |
| 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 LightTherapy device | Celluma | LG PRA.L DERMA LEDMASK |
|---|---|---|---|---|---|
| 510(k)Number | Pending | K171390 | K140471 | K171323 | K183671 |
| Manufacturer | MyBlend | LED Technologies Inc. | LA LUMIERE, LLC | BIOPHOTAS Inc. | LG Electronics, Inc. |
| Device Tradename | MyLedMAsk | DPL II PANEL | PRO X OTC 5 Light Therapydevice | Celluma | LG PRA.L DERMA LEDMASK |
| Class | 2 | ||||
| Product Code | OHS - Light based OTC for wrinkle reduction | ||||
| Indicationsfor Use | MyLedMask is an over-the-counter device that is intendedto emit energy in the visibleand infrared region of thespectrum for use in thetreatment of full-face wrinkles | The dp®II Panel System isan Over The Counter(OTC) device intended foruse in treating wrinkles. | The Pro X OTC 5 is an Over-The-Counter deviceintended for use in thetreatment of facial wrinkles.It is for people with wrinkleson their face and who have | The BioPhotas Celluma3is intended to emitenergy in the visible andinfrared region of thespectrum for use in thetreatment of full-facewrinkles. | The LG PRA.L DERMA LEDMASK is an over-the-counter device that isintended for the use inthe treatment of full-facewrinkles. |
| Property | MyLedMask | DPL II PANEL | PRO X OTC 5 LightTherapy device | Celluma | LG PRA.L DERMA LEDMASK |
| Fitzpatrick skin types I, II | |||||
| and/or III.Calculated at 325 cm² | |||||
| TreatmentArea (cm2) | About 72 cm² estimated fromthe LED Mask dimension | 415 cm² | (Overall total Energy 332 Jand Total Dose Energy 1.02J/cm²) | Active treatment area of15″ x 8″ (381 mm x 203mm): about 77 cm² | 178.8 x 225 x 89: about50 cm² estimated fromthe LED Mask dimension |
| Materials | Mask inner face: MAKROLON2805Protective eye cup: SiliconTN750Elastic band holder: Neoprenand Polycotton | Not known | Not known | Not known | Mask frame: PCEye frame: PPEye shield: SiliconeViewing shield: ABSplasticController frame: PPAdaptor frame: PPCradle frame: PP |
| Dimension(mm) | LED mask: 176 x 342 x 122Storage case: 365 x 225 x 150 | Not known | Not known | Not known | LED Mask: 178.8 x 225 x89Controller: 40 x 30 x 110Adaptor: 87x 44 x 28Cradle: 180 x 229 x 167.8 |
| Net weight(g) | LED mask: 650 gStorage case: 623 g | Not known | Not known | Not known | LED Mask: 225 g /Controller: 84 gAdaptor: 75 g / Cradle:380 g |
| LED Emission | Red: 630 nm (OSRAM LS T67F)NIR: 850 nm (OSRAM SFH 4253) | 605 nm, 630 nm, 660 nm,880 nm | red light (620-630nm)infrared light (855nm) | Red: 640nm+/-25nmNIR: 880nm+/-50nm | RED (637 nm)IR (854 nm) |
| Number ofLEDs | Total 288 LEDs- 144 for 630 nm and 144 for850 nm- 244 for the face and 44 for theneck | Not known | Not known | Not known | Total 160 LEDs (80 ofthem arefor 637 nm and the rest80 ofthem are for 854 nm) |
| LED Power | 18.7 mW/cm²(average of 6 measurementlocation (including one on theneck) between 10 to 27mW/cm2) | 70.16 mW/cm² | 16 mW/cm² (red)2.9 mW/cm2 (infrared)Total : 18.9 mW/cm² | 6.5 mW/cm² | 25 mW/cm² total |
| Irradiance | According to skin phototype:- 1 fair skin: 6.3 J/cm²- 2 moderately dark skin: 12.5 J/cm²- 3 dark skin: 15.6 J /cm² | 12.6 J/cm²Calculated from Power(70.16 mW/cm2) andTreatment duration 3 min(180 s) | 0.86 J/cm² (red)0.16 J/cm² (infrared)Total : 1.02 J/cm² | 11.7 J/cm² | 13.5 J/cm²Calculated from Power(25 mW/cm²) andTreatment duration 9 min(540 s) |
| TreatmentTime | According to skin phototype,daily- 1 fair skin: 5 min 35 (335 s)- 2 moderately dark skin: 11min 10 (670 s)- 3 dark skin: 13 min 55 (835 s)during 6 to 8 weeks | 3 minutes daily5 days per week for 8weeks | 900 seconds per treatment60 times | 3 treatments per week(1800 seconds)- 4 weeks | 9 minutes daily5 days per week for 8weeks |
| Total EnergyDose (J/cm2) | For 8 weeks, 3.5 Treatments(48 h spaced) per week:According to skin phototype:- 1 fair skin: 176 J- 2 moderately dark skin: 350 J- 3 dark skin: 437 J | For 8 weeks, 5Treatments per week :504 J/cm² | For 60 treatments of 900 s :61.2 J/cm² | For 4 weeks, 3Treatments per week :140 J | For 8 weeks, 5Treatments per week :540 J |
| TreatmentControl | Device uses a timer andsoftware to controltreatment duration.Software Safety Class: A (Lowlevel of concern) | Not known | Not known | Device uses a timer andsoftware to controltreatment duration.Software Safety Class: A(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, ACFrequency: 50-60HzIntensity: 0.35 A | 120-240 V AC | Not known | 110-120V | Input: AC 100V ~ 240VFrequency: 50Hz/60HzOutput: 5V 2A |
| Property | MyLedMask | DPL II PANEL | PRO X OTC 5 LightTherapy device | Celluma | LG PRA.L DERMA LEDMASK |
| ElectricalSafety | 60601-2-57:201160601-1:201260601-1-2:2014 | 60601-1:200660601-1-2:2007 | 60601-1:200660601-1-2:200762471 | 60601-1:201260601-1-2:2007 | 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.
§ 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.