(84 days)
Not Found
No
The device description focuses on the use of LEDs at specific wavelengths for light therapy and does not mention any AI/ML components or functionalities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes.
The device is indicated for the treatment of full face wrinkles and mild to moderate acne, which are therapeutic indications.
No
The device is indicated for treatment (full face wrinkles and mild to moderate acne) and does not perform any diagnostic function.
No
The device description explicitly details hardware components such as LEDs, a facemask shape, a USB power cord, and an integrated module. It also mentions physical interaction (wearing the device, pressing a power button) and physical effects (light emission). This indicates it is a hardware device with potentially embedded software, not a software-only medical device.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Project E Beauty LED Light Therapy Mask is a device that applies light directly to the skin for therapeutic purposes (treating wrinkles and acne). It does not analyze any biological samples.
- Intended Use: The intended use is for the treatment of conditions on the face, not for analyzing samples to diagnose or monitor a disease.
Therefore, the Project E Beauty LED Light Therapy Mask falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Project E Beauty LED Light Therapy Mask is an over the counter device that is indicated for the treatment of full face wrinkles and mild to moderate acne.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
The Project E Beauty LED Light Therapy Mask is a facemask-shaped device designed for home-use, which uses Light Emitting Diodes to emit energy in the red, blue and infrared region of the spectrum.
The Project E Beauty LED Light Therapy Mask has a total of 36 LEDs. The red light with wavelengths centered at 635-644nm and the infrared light with wavelengths centered at 845-855nm to treat wrinkles on the face. The blue light with wavelengths centered at 430-445nm and the red light with wavelengths centered at 635-644nm to treat mild to moderate acne on the face.
The Project E Beauty LED Light Therapy Mask components include the LED module, USB power cord, and integrated module. The user wears the device over the face, like a pair of glasses, and presses the Power button on the integrated module for 1 second to initiate the treatment. The device has a continuous working time of 12 minutes and powers off automatically.
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
Home-use / 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)
The Project E Beauty LED Light Therapy Mask has been evaluated the safety and performance by lab bench testing and conforms to the following international consensus standards:
Electrical safety:
- ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 ● (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
EMC: - IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment Part 1-2: General Requirements For ● Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests;
Additional safety testing: - IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment;
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems;
- IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: 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, Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems;
Biocompatibility testing: - ISO 10993-5 Third edition 2009-06-01, Biological Evaluation Of Medical Devices -- Part 5: Tests For ● In Vitro Cytotoxicity.
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Performance testing discussed above was conducted with the device to show that it can perform safely and effectively.
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.
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
§ 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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
March 23, 2022
Duplex International Trading Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K214101
Trade/Device Name: Project E Beauty LED Light Therapy Mask (Model: PE730) 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: December 22, 2021 Received: December 29, 2021
Dear Doris Dong:
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 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.
Purva Pandya, D.Eng. 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
2
Indications for Use
510(k) Number (if known) K214101
Device Name Project E Beauty LED Light Therapy Mask
Indications for Use (Describe)
The Project E Beauty LED Light Therapy Mask is an over the counter device that is indicated for the treatment of full face wrinkles and mild to moderate acne.
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
K214101
510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K214101 |
|---|---|
| Date: | March 16th, 2022 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Owner: | Duplex International Trading Limited |
| B1, 10/F, Block 2, Golden Dragon Ind Centre, 162-170 Tai Lin Pai Road | |
| Kwai Chung, NT, Hong Kong, China | |
| Tel: +852-31063608 | |
| Email: sales@projectebeauty.com | |
| Contact: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description
| Proprietary Name: | Project E Beauty LED Light Therapy Mask |
|---|---|
| Model: | PE730 |
| Classification Name: | Light Based Over The Counter Wrinkle Reduction (OHS) |
| Over-The-Counter Powered Light Based Laser For Acne (OLP) | |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | OHS, OLP |
| Device Class: | II |
| Review Panel: | General & Plastic Surgery |
| Device Description: | The Project E Beauty LED Light Therapy Mask is a facemask-shaped device |
| designed for home-use, which uses Light Emitting Diodes to emit energy in the red, | |
| blue and infrared region of the spectrum. | |
| The Project E Beauty LED Light Therapy Mask has a total of 36 LEDs. The red | |
| light with wavelengths centered at 635-644nm and the infrared light with | |
| wavelengths centered at 845-855nm to treat wrinkles on the face. The blue light with | |
| wavelengths centered at 430-445nm and the red light with wavelengths centered at | |
| 635-644nm to treat mild to moderate acne on the face. | |
| The Project E Beauty LED Light Therapy Mask components include the LED | |
| module, USB power cord, and integrated module. The user wears the device over | |
| the face, like a pair of glasses, and presses the Power button on the integrated | |
| module for 1 second to initiate the treatment. The device has a continuous working | |
| time of 12 minutes and powers off automatically. | |
| Indications for use: | The Project E Beauty LED Light Therapy Mask is an over the counter device that is |
| indicated for the treatment of full face wrinkles and mild to moderate acne |
4
3. Predicate Device Identification
| Predicate 510(k) Number: | K180856 | K180847 |
|---|---|---|
| Marketing clearance date: | June 19, 2018 | June 19, 2018 |
| Product name: | Neutrogena Light Therapy Aging Mask+ | Neutrogena Light Therapy Acne Mask+ |
| Manufacturer: | Johnson & Johnson Consumer, Inc. | Johnson & Johnson Consumer, Inc. |
4. Substantial Equivalence to Predicate device
Detailed comparison data is included in "Section 10 - Substantial Equivalence Discussion" of this 510(k) submission.
| Parameters | New Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| 510(k) number | K214101 | K180856 | K180847 | -- |
| Owner | Duplex International Trading Limited | Johnson & Johnson Consumer, Inc. | Johnson & Johnson Consumer, Inc. | -- |
| Device name | Project E Beauty LED Light Therapy Mask | Neutrogena Light Therapy Aging Mask+ | Neutrogena Light Therapy Acne Mask+ | -- |
| Model | PE730 | / | / | -- |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | II | II | II | Same |
| Product code | OHS, OLP | OHS | OLP | Similar |
| Indication for use | The Project E Beauty LED Light Therapy | |||
| Mask is an over the counter device that is | ||||
| indicated for the treatment of full face | ||||
| wrinkles and mild to moderate acne. | The Neutrogena Light Therapy Aging Mask+ | |||
| is an over the counter device that is indicated | ||||
| for the treatment of full face wrinkles. | The Neutrogena 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. | -- | |||
| Target population | Individuals with wrinkles and/or mild to | |||
| moderate acne on the face | Individuals with wrinkles on the face | Individuals with mild to moderate acne on the | ||
| face | -- | |||
| Location for use | OTC | OTC | OTC | Same |
| Anatomical site | Full face | Full face | Full face | Same |
| Type | Mask | Mask | Mask | Same |
| Irradiance source | LED | LED | LED | Same |
| Visible light LEDs | Yes | Yes | Yes | Same |
5
| LED Array | 36 LEDs | No publicly available | 12 LEDs | Similar |
|---|---|---|---|---|
| Light spectrum | ||||
| region | Mode 1: Red +IR light | |||
| Mode 2: Red +Blue light | Red light, IR light | |||
| -- | -- | |||
| Red light, Blue light | Same | |||
| wavelengths | Mode 1: | |||
| Red: 635-644nm; IR: 845-855nm | ||||
| Mode 2: | ||||
| Red: 635-644nm; Blue: 430-445nm | Red: 620-640nm; IR: 820-880nm | |||
| -- | -- | |||
| Red: 620-640nm; Blue: 425-450nm | ||||
| Energy Level | Mode 1: 1.07 mW/cm² | |||
| Mode 2: 1.75 mW/cm² | 1.32 mW/cm² | |||
| -- | -- | |||
| 2.13mW/cm² | ||||
| Total Energy Dose | Mode 1: 46.24 J/cm² | |||
| Mode 2: 37.87 J/cm² | 47.58 J/cm² | |||
| -- | -- | |||
| 38.38 J/cm² | ||||
| Treatment Time | Mode 1: 12 minutes/day for 60 sessions | |||
| Mode 2: 12 minutes/day for 30 sessions | 10 minutes/day for 60 sessions | |||
| -- | -- | |||
| 10 minutes/day for 30 sessions | ||||
| Power Supply | Li-Ion rechargeable batteries | Nickel-Metal Hydride rechargeable batteries | Ni-MH Batteries | Similar |
| Material | ABS, PC, PET | Not publicly available | Not publicly available | |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | Meet FDA's Requirements | Same |
6
K214101
4. Non-clinical Testing
The Project E Beauty LED Light Therapy Mask has been evaluated the safety and performance by lab bench testing and conforms to the following international consensus standards:
Electrical safety:
- ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 ● (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
EMC:
-
IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment Part 1-2: General Requirements For ● Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests;
Additional safety testing: -
IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment;
-
IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems;
-
IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: 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, Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems;
Biocompatibility testing:
- ISO 10993-5 Third edition 2009-06-01, Biological Evaluation Of Medical Devices -- Part 5: Tests For ● In Vitro Cytotoxicity.
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
5. Conclusions
The Project E Beauty LED Light Therapy Mask has technological characteristics that are similar to the predicate devices, and when compared to the predicate devices it does not raise new types of questions regarding the safety and efficacy for the above indications for use. Performance testing discussed above was conducted with the device to show that it can perform safely and effectively. The proposed Project E Beauty LED Light Therapy Mask is considered to be substantially equivalent to the predicate devices K180847 and K180856.