(85 days)
Not Found
No
The summary describes a device that uses LED light therapy with different wavelengths and modes. There is no mention of any AI or ML components, image processing, or data analysis that would suggest the use of such technologies. The performance studies focus on electrical safety and electromagnetic compatibility, not algorithmic performance.
Yes
The device is described as treating medical conditions such as wrinkles, acne, arthritis, and muscle spasms, and its intended use includes therapeutic effects like relieving stiffness, promoting muscle relaxation, and increasing blood circulation. It also references medical device standards (IEC 60601 series).
No
The device is described as a treatment device using LED light therapy for conditions like wrinkles and acne, not for diagnosing them. Its intended uses explicitly state "Treatment of full-face wrinkles" and "Treatment of mild to moderate inflammatory acne."
No
The device description explicitly states it is a "wearable LED phototherapy device" consisting of a "main unit (mask), controller, Type-C charging cable and so on," indicating it is a hardware device that utilizes LED light for treatment.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device uses LED light therapy applied directly to the skin for therapeutic purposes (treating wrinkles and acne, providing topical heating). It does not analyze any biological samples.
- Intended Use: The intended use clearly describes treatment of conditions on the skin, not diagnostic testing of samples.
- Device Description: The description focuses on the physical components and the mechanism of light emission and absorption by the skin.
- Performance Studies: The performance studies mentioned are related to electrical safety and electromagnetic compatibility, which are typical for therapeutic devices, not IVDs.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- Red+Infrared light: Treatment of full-face wrinkles.
- Red light: Treatment of full-face wrinkles.
- Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
- Blue light: Treatment of mild to moderate inflammatory acne.
- Red+Blue light: Treatment of mild to moderate inflammatory acne.
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Product codes
OHS, OLP, ILY
Device Description
The LED Light Therapy Mask adopts light emitting diodes (LED) in the infrared, red and blue spectrum to irradiate on the skin. The face will absorb the light energy to achieve the effects. The LED Light Therapy Mask is applied directly to the skin to ensure consistent administration of light during each treatment. LED Light Therapy Mask is a home use wearable LED phototherapy device which can help reduce wrinkles and arovide topical heating, It is consisting of main unit(mask), controller, Type-C charging cable and so on.
The RB-081 outputs 5 kinds of treatment modes: red infrared, blue, red+blue light. The RB-030 outputs 4 kinds of treatment modes: red-infrared, red, infrared, blue light. The RB-008 outputs 3 kinds of treatment modes: red+infrared, red, blue light. The RB-008G/ RB-008GB/RB-008J/RB-008JB output 4 kinds of treatment modes: red+infrared, red, blue light.
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
adults
Intended User / Care Setting
home healthcare environment
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
Non-clinical tests have been conducted to verify that the Light Therapy Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results device complies with the following standards:
- IEC 60601-1:2020, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2021, Medical electrical equipments for basic safety and essential performance -Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11:2020, Medical electrical equipments for basic safety and essential performance --
Key Metrics
Not Found
Predicate Device(s)
K241857, K230351, K241102, K160691, K223544
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
January 28, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym with the full name of the agency on the right. The seal features an emblem with a stylized design, while the FDA acronym is in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Shenzhen Rainbow Technology Co., Ltd. % Jilan Luo RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China
Re: K243423
Trade/Device Name: LED Light Therapy Mask (Model(s): RB-008, RB-031, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) 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, ILY Dated: October 31, 2024 Received: November 4, 2024
Dear Jilan Luo:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows the name "YAN FU -S" in large, bold letters. To the right of the name, there is a digital signature that reads "Digitally signed by YAN FU -S" followed by the date and time "Date: 2025.01.28 16:52:13". Below the date and time, there is a timezone offset of "-05'00'".
for Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K243423
Device Name
LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008GB, RB-008J, RB-008JB)
Indications for Use (Describe)
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Red+Infrared light: Treatment of full-face wrinkles.
-
Red light: Treatment of full-face wrinkles.
-
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
-
Blue light: Treatment of mild to moderate inflammatory acne.
-
Red+Blue light: Treatment of mild to moderate inflammatory acne.
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
| 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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| 510(k) #: K243423 | 510(k) Summary | Prepared on: 2025-01-27 | |||
|---|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||||
| Applicant Name | Shenzhen Rainbow Technology Co.,Ltd. | ||||
| Applicant Address | 5th floor, Building C, Fenda Technology Innovation Park, Xixiang, Baoan | ||||
| District Shenzhen Guangdong 518000 China | |||||
| Applicant Contact Telephone | 86 13590329742 | ||||
| Applicant Contact | Ms. Layla Li | ||||
| Applicant Contact Email | Layla@rainbowdo.com | ||||
| Correspondent Name | Feiying Drug & Medical Consulting Technical Service Group | ||||
| Correspondent Address | Rm 2401 Zhenye International Business Center, No. 3101-90, | ||||
| Qianhai Road Shenzhen Guangdong 518052 China | |||||
| Correspondent Contact Telephone | +86 13535208704 | ||||
| Correspondent Contact | Ms. Jilan Luo | ||||
| Correspondent Contact Email | jilan.luo@qq.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | LED Light Therapy Mask (Model(s): RB-008, RB-030, | ||||
| RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) | |||||
| Common Name | Laser surgical instrument for use in general and plastic surgery and in | ||||
| dermatology | |||||
| Classification Name | Light Based Over The Counter Wrinkle Reduction | ||||
| Regulation Number | 21 CFR 878.4810, 21 CFR 890.5500 | ||||
| Product Code(s) | OHS, OLP, ILY | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K241857 | LED Light Therapy Device | OHS, OLP, ILY | |||
| K230351 | LED Facial Mask | OHS, OLP | |||
| K241102 | Luna 4 Plus | OHS, NFO | |||
| K160691 | Acne Light Therapy Wand | OLP | |||
| K223544 | LED Light Therapy Mask | OHS, OLP, ILY |
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Device Description Summary
The LED Light Therapy Mask adopts light emitting diodes (LED) in the infrared, red and blue spectrum to irradiate on the skin. The face will absorb the light energy to achieve the effects. The LED Light Therapy Mask is applied directly to the skin to ensure consistent administration of light during each treatment. LED Light Therapy Mask is a home use wearable LED phototherapy device which can help reduce wrinkles and arovide topical heating, It is consisting of main unit(mask), controller, Type-C charging cable and so on.
The RB-081 outputs 5 kinds of treatment modes: red infrared, blue, red+blue light. The RB-030 outputs 4 kinds of treatment modes: red-infrared, red, infrared, blue light. The RB-008 outputs 3 kinds of treatment modes: red+infrared, red, blue light. The RB-008G/ RB-008GB/RB-008J/RB-008JB output 4 kinds of treatment modes: red+infrared, red, blue light.
Intended Use/Indications for Use
�Red+Infrared light: Treatment of full-face wrinkles.
മRed light: Treatment of full-face wrinkles.
�lnfrared light: Provide topical heating tissue temperature; arthritis and muscle spasm;relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
ØBlue light: Treatment of mild to moderate inflammatory acne.
�Red+Blue light: Treatment of mild to moderate inflammatory acne.
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Indications for Use Comparison
The LED Light Therapy Mask have the same indications for use as the predicate devices.
Technological Comparison
The technical characteristics of LED Light Therapy Mask (Models:RB-008, RB-008G, RB-0008GB, RB-008J, RB-008J) are substantially equivalent to the predicate devices in the following aspects:
1.the indications for use of LED Light Therapy Mask are within the range of all predicate devices.
2.similar power supply: the product uses lithium batteries, which were tested according to FDA guidance documents and the requirements of IEC 62133-2, the tests are all passed.
3.same wavelength: the LED Light Therapy Mask has the same wavelengths (red: 620mm, infrared: 850nm) as K223544 and they all comply with IEC 60601-2-83 and IEC 62471 requirements, so it will not raise any safety or effectiveness issue.
4.similar irradiance though the irradiance of subject device is a little different from the predicate devices, the irradiance of subject device is within the range of the minimum value of the predicate device and reference predicate devices, and the subject device complies with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue. The evaluation process is as follows:
a. Red+lR light: the irradiance of subject device (45.5mW/cm2) is between the range of K241857 (30mW/cm2) and K241102 (63mW/ cm2).
b. Red light: the irradiance of subject device (53.2mW/cm2) is within the range of the red light irradiance (31~75mW/cm2) of K230351. c. Infrared light: the irradiance of subject device (4mW/cm2) is the same as the K223544.
d. Blue light the irradiance of subject device (58.7mW/cm2) is within the range of the blue light irradiance (15~63mW/cm2) of K230351.
- e. Red and blue light: the irradiance of subject device (33.6mW/cm2) is similar with the K160691(34mW/cm2).
-
the same safety features: Type BF applied part.
-
dimension and weight: though the dimension and weight are a little different from the predicate devices, this difference is insignificant and do not raise any safety or effectiveness problems.
Therefore, the LED Light Therapy Mask is substantially equivalent to its predicate device and reference predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical tests have been conducted to verify that the Light Therapy Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results device complies with the following standards:
-
IEC 60601-1:2020, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance 2. IEC 60601-1-2:2021, Medical electrical equipments for basic safety and essential performance -Collateral standard: Electromagnetic disturbances - Requirements and tests
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IEC 60601-1-11:2020, Medical electrical equipments for basic safety and essential performance --
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)