(221 days)
Not Found
No
The description focuses on LED light therapy with pre-set programs based on skin phototype, controlled by a microcontroller, with no mention of AI or ML capabilities.
Yes
Explanation: The device is intended for "treatment of full-face wrinkles," which indicates a therapeutic purpose.
No
The device is intended for treatment (reduction of wrinkles) and does not mention any diagnostic capabilities.
No
The device description explicitly mentions hardware components such as LEDs, a microcontroller, rechargeable batteries, an external charger, and protective eye-shields.
Based on the provided information, the myLEDmask device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The myLEDmask device is a light therapy device that applies energy directly to the skin for the treatment of wrinkles. It does not involve the analysis of any biological specimens.
The intended use and device description clearly indicate it's a therapeutic device, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
OHS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face and neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
No clinical Performance data are included in this submission. However, based on FDA guidance, usability has been evaluated with panel of representative users.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K171390, K140471, K171323, K183671
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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 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, France | |
| Tel : +33 1 56 60 65 35 |
2. Submission correspondent
| Contact Person | Cnnsultant | José PEREZ/ Laetitia ROBIN |
|---|---|---|
| CEISO 69 Rue de PARIS, 91400 ORSAY | ||
| Phone: +33 6 27 30 01 94 / +33 6 42 19 30 64 | ||
| Email: jose.perez@ceiso.fr / laetitia.robin@ceiso.fr | ||
| Manufacturer | Clédia HETTINGER | |
| Assistant & Coordinator | ||
| Phone: +33 6 89 08 11 79 | ||
| Address: 12 Avenue de la Porte des Ternes 7017 Paris | ||
| Mail: cledia.hettinger@clarins.com | ||
| Specification Developper/ | ||
| Contract Manufacturer | Hanan BERNARDELLI | |
| CEO MOSTLEDS | ||
| Phone: +33 6 85 14 26 08 | ||
| Address: 1432 Quai Marcel Dassault 92210 Saint-Cloud France | ||
| Email 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 92805
USA | LG Electronics, Inc
Gyeonggi-do, 17709,
Rep. of Korea |
|-----------------------|----------------------|-------------------------------------|---------------------------------------------|-------------------------------------------------------------|
| Device Name : | DPL II PANEL | PRO X OTC 5 Light
Therapy device | Biophotas Celluma3 | LG PRA.L DERMA LED
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
Therapy device | Celluma | LG PRA.L DERMA LED
MASK |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | Pending | K171390 | K140471 | K171323 | K183671 |
| Manufacturer | MyBlend | LED Technologies Inc. | LA LUMIERE, LLC | BIOPHOTAS Inc. | LG Electronics, Inc. |
| Device Trade
name | MyLedMAsk | DPL II PANEL | PRO X OTC 5 Light Therapy
device | Celluma | LG PRA.L DERMA LED
MASK |
| Class | 2 | | | | |
| Product Code | OHS - Light based OTC for wrinkle reduction | | | | |
| 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 | The dp®II Panel System is
an Over The Counter
(OTC) device intended for
use in treating wrinkles. | The Pro X OTC 5 is an Over-
The-Counter device
intended for use in the
treatment of facial wrinkles.
It is for people with wrinkles
on their face and who have | The BioPhotas Celluma3
is intended to emit
energy in the visible and
infrared region of the
spectrum for use in the
treatment of full-face
wrinkles. | The LG PRA.L DERMA LED
MASK is an over-the-
counter device that is
intended for the use in
the treatment of full-face
wrinkles. |
| Property | MyLedMask | DPL II PANEL | PRO X OTC 5 Light
Therapy device | Celluma | LG PRA.L DERMA LED
MASK |
| | | | Fitzpatrick skin types I, II | | |
| | | | and/or III.
Calculated at 325 cm² | | |
| Treatment
Area (cm2) | About 72 cm² estimated from
the LED Mask dimension | 415 cm² | (Overall total Energy 332 J
and Total Dose Energy 1.02
J/cm²) | Active treatment area of
15″ x 8″ (381 mm x 203
mm): about 77 cm² | 178.8 x 225 x 89: about
50 cm² estimated from
the LED Mask dimension |
| Materials | Mask inner face: MAKROLON
2805
Protective eye cup: Silicon
TN750
Elastic band holder: Neopren
and Polycotton | Not known | Not known | Not known | Mask frame: PC
Eye frame: PP
Eye shield: Silicone
Viewing shield: ABS
plastic
Controller frame: PP
Adaptor frame: PP
Cradle frame: PP |
| Dimension
(mm) | LED mask: 176 x 342 x 122
Storage case: 365 x 225 x 150 | Not known | Not known | Not known | LED Mask: 178.8 x 225 x
89
Controller: 40 x 30 x 110
Adaptor: 87x 44 x 28
Cradle: 180 x 229 x 167.8 |
| Net weight
(g) | LED mask: 650 g
Storage case: 623 g | Not known | Not known | Not known | LED Mask: 225 g /
Controller: 84 g
Adaptor: 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+/-25nm
NIR: 880nm+/-50nm | RED (637 nm)
IR (854 nm) |
| Number of
LEDs | Total 288 LEDs
- 144 for 630 nm and 144 for
850 nm - 244 for the face and 44 for the
neck | Not known | Not known | Not known | Total 160 LEDs (80 of
them are
for 637 nm and the rest
80 of
them are for 854 nm) |
| LED Power | 18.7 mW/cm²
(average of 6 measurement
location (including one on the
neck) between 10 to 27
mW/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/cm²
Calculated from Power
(70.16 mW/cm2) and
Treatment 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/cm²
Calculated from Power
(25 mW/cm²) and
Treatment duration 9 min
(540 s) |
| Treatment
Time | According to skin phototype,
daily - 1 fair skin: 5 min 35 (335 s)
- 2 moderately dark skin: 11
min 10 (670 s) - 3 dark skin: 13 min 55 (835 s)
during 6 to 8 weeks | 3 minutes daily
5 days per week for 8
weeks | 900 seconds per treatment
60 times | 3 treatments per week
(1800 seconds)- 4 weeks | 9 minutes daily
5 days per week for 8
weeks |
| Total Energy
Dose (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, 5
Treatments per week :
504 J/cm² | For 60 treatments of 900 s :
61.2 J/cm² | For 4 weeks, 3
Treatments per week :
140 J | For 8 weeks, 5
Treatments per week :
540 J |
| Treatment
Control | Device uses a timer and
software to control
treatment duration.
Software Safety Class: A (Low
level of concern) | Not known | Not known | Device uses a timer and
software to control
treatment 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, AC
Frequency: 50-60Hz
Intensity: 0.35 A | 120-240 V AC | Not known | 110-120V | Input: AC 100V ~ 240V
Frequency: 50Hz/60Hz
Output: 5V 2A |
| Property | MyLedMask | DPL II PANEL | PRO X OTC 5 Light
Therapy device | Celluma | LG PRA.L DERMA LED
MASK |
| Electrical
Safety | 60601-2-57:2011
60601-1:2012
60601-1-2:2014 | 60601-1:2006
60601-1-2:2007 | 60601-1:2006
60601-1-2:2007
62471 | 60601-1:2012
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.