(90 days)
No
The device description and performance studies focus on light irradiation and electrical/safety standards, with no mention of AI or ML capabilities.
Yes
The device is indicated for the "treatment of full face wrinkles," which is a claim for a therapeutic effect.
No
This device is indicated for the treatment of full face wrinkles, not for diagnosing any condition. It irradiates the skin with light for therapeutic purposes.
No
The device description clearly outlines a physical mask with built-in battery, LEDs, and charging components, indicating it is a hardware device, not software-only.
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.
- Device Function: The LED MASK PLATINUM MD is a light therapy device that applies red and infrared light directly to the skin for the treatment of wrinkles. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is for the "treatment of full face wrinkles," which is a therapeutic application, not a diagnostic one.
Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
LED MASK PLATINUM MD is an over the counter device that is indicated for the treatment of full face wrinkles.
Product codes
OHS
Device Description
This product irradiates the skin with red light in the wavelength range of 630 to 690 nm and infrared light in the wavelength range of 820 to 880 nm. Treatment of wrinkles all over the face.
This product is designed as a portable personal medical device with a built-in battery, not a wired power supply. It is a mask-type product that is worn on the face. The operating mode of the product can be easily changed by hand. After connecting the charging adapter to the cradle, attach the main unit to the cradle to wirelessly charge the main unit with only the cradle. In addition, eye shield (for eye protection, opening/closing covers, vacuum cleaner towels, power cables, etc. are provided for convenient service use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
full face
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)
Non-clinical tests: Measurement of wavelength, average output power, and total irradiance (power density, in units of J/cm2) of treatment LEDs performance, such as safety of laser product, were performed. Other electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards:
Basic safety and essential performance of the LED MASK PLATINUM MD is tested and evaluated according to the FDA-recognized consensus standard, ES 60601-1. Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2.
- Safety of laser product is evaluated in accordance with IEC 62471, and IEC 60601-2-57.
- Risk management was recorded by referring to ISO 14971.
- Usability was documented by referring to IEC 60601-1-6.
- Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment were tested with IEC 60601-1-11.
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.
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.
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
§ 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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
November 3, 2022
CellReturn Co., LTD. % Do-Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, Seoul 06210 Korea. South
Re: K222377
Trade/Device Name: Led Mask Platinum Md 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: August 1, 2022 Received: August 5, 2022
Dear Do-Hyun Kim:
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, PhD 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) K222377
Device Name
LED MASK PLATINUM MD
Indications for Use (Describe)
LED MASK PLATINUM MD is an over the counter device that is indicated for 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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3
LED MASK PLATINUM MD 510(k) Summary
5. 510(k) Summary
5.1 General Information
| Applicant/Submitter: | Cellreturn Co.,Ltd. |
|---|---|
| Address: | 237, Namdongseo-ro, Namdong-gu, |
| Incheon, Republic of Korea, 21634 | |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 904, Eonju-ro 86gil 5, |
| Gangnam-gu, Seoul 06210, Korea. | |
| Tel: +82-2-538-9140 | |
| Email: ceo@btsolutions.co.kr | |
| Preparation Date: | August 4, 2022 |
5.2 Device Name and Code
| Device Trade Name: | LED MASK PLATINUM MD |
|---|---|
| Model Name: | MQ-M21M4 |
| Classification Name: | Light Based Over The Counter Wrinkle Reduction |
| Product Code: | OHS |
| Regulation Number: | 21 CFR 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
5.3 Technical Characteristics in Comparison to Predicate Devices
The LED MASK PLATINUM MD, is substantially equivalent to the following legally marketed predicate devices
| Proposed Device | K180856 | |
|---|---|---|
| Company | LED Mask Platinum MD | Neutrogena Light Therapy |
| Aging Mask+ | ||
| Product name | Cellreturn Co.,Ltd. | Johnson & Johnson Consumer Inc. |
| Product code | OHS | OHS |
| Regulation | ||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Classification | Class II | Class II |
| Intended Use | LED MASK PLATINUM MD is | |
| an over the counter device that is | ||
| indicated for the treatment of full | ||
| face wrinkles. | The Neutrogena Light Therapy | |
| Aging Mask+ is an over the | ||
| counter device that is indicated |
4
510(k) Summary
| | | for the treatment of full face
wrinkles. |
|----------------------------------|--------------------------|---------------------------------------------|
| Type of use | OTC | OTC |
| Technological
characteristics | | |
| Shape of device | Mask type | Mask type |
| Wavelength | 630-690 nm
820-880 nm | 620-640 nm
820-880 nm |
| Power
(mW/cm2) | 2 | 1.32 |
| Treatment time
(min) | 8 | 10 |
| Energy dose
(J/cm2) | 0.96 | 0.79 |
Irradiance of already cleared OTC device that is intended for the treatment of full face wrinkles ranges from 1.32 mW/cm2 (K180856) to 62 mW/cm2 (K133896), which means irradiance that lies between these two values can be regarded as "safe" to use for the intended purpose.
5.4 Device Description
This product irradiates the skin with red light in the wavelength range of 630 to 690 nm and infrared light in the wavelength range of 820 to 880 nm. Treatment of wrinkles all over the face.
This product is designed as a portable personal medical device with a built-in battery, not a wired power supply. It is a mask-type product that is worn on the face. The operating mode of the product can be easily changed by hand. After connecting the charging adapter to the cradle, attach the main unit to the cradle to wirelessly charge the main unit with only the cradle. In addition, eye shield (for eye protection, opening/closing covers, vacuum cleaner towels, power cables, etc. are provided for convenient service use.
5.5 Indications / Intended Use
LED MASK PLATINUM MD is an over the counter device that is indicated for the treatment of full face wrinkles.
6.6 Performance Data
tests: Measurement of wavelength, average output power, Non-clinical and density, in in units of of J/cm2) of treatment total irradiance (power LEDs performance, such as safety of laser product, were performed. Other electromagnetic compatibility and electrical safety, etc, were tested using following consensus the
Basic safety and essential performance of the LED MASK PLATINUM MD is tested and evaluated according to the FDA-recognized consensus standard, ES 60601-1. Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2.
5
510(k) Summary
- -Safety of laser product is evaluated in accordance with IEC 62471, and IEC 60601-2-57.
- Risk management was recorded by referring to ISO 14971. -
- -Usability was documented by referring to IEC 60601-1-6.
- -Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment were tested with IEC 60601-1-11.
5.7 Substantial Equivalence
The proposed device uses similar or identical technology as the predicate devices and has same intended uses. Based upon the predicted overall performance characteristics for LED MASK PLATINUM MD , Cellreturn Co.,Ltd.. believes that no significant differences in usage of its underlying technological principles between LED MASK PLATINUM MD and the predicate device.
5.8 Conclusions
On the basis of the information provided in this summary, Cellreturn Co.,Ltd. believes that LED MASK PLATINUM MD is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.