(140 days)
No
The device description and performance studies focus on the physical properties of the LED light therapy and electrical safety, with no mention of AI or ML algorithms for analysis, control, or personalization.
Yes
The device is intended for the "treatment of full-face wrinkles," which is a therapeutic purpose.
No
The device is intended for the treatment of full-face wrinkles using LED light therapy, not for diagnosing any medical condition.
No
The device description clearly outlines physical hardware components including a flexible silicone mask with LEDs, a controller with a rechargeable battery, and a power supply. It is a hardware device that utilizes light therapy.
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 LED Light Therapy Mask is a phototherapy device that applies 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 device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
Product codes
OHS
Device Description
The LED LIGHT THERAPY MASK is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles.
The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of sillcone.
The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The LED LIGHT THERAPY MASK cannot be operated while charging. The controller switches the LEDs ON/OFF and controls power to the mask. The device does not have an adapter, please use adapters of the following specifications: input: 100-240Va.c., 50Hz/60Hz, output: DC 5V, 2A.
The device produces red and near infra-red (NIR) light in the visible spectrum (Red: 630+/-5nm, NIR: 830nm) in intended to improve the appearance of wrinkles. The controller switches the LEDs ON/OFF and controls power to the mask. And the cable for connecting with the controller is non-detachable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home wearable / 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
Non-Clinical Performance Testing:
Testing was performed to evaluate the safety and performance of the LED LIGHT THERAPY MASK (Model: MK66R-B).
Test Type: General requirements for basic safety and essential performance
Sample Size: The test sample is the final, finished product of representative model: MK66R-B
Standard: IEC 60601-1:2005+A1:2012+A2:2020 Edition: 3.2 2020-08
Results: Pass. The test result is within the test acceptance range of the standard.
Test Type: Electromagnetic disturbances
Sample Size: The test sample is the final, finished product of representative model: MK66R-B
Standard: IEC 60601-1-2:2014+A1:2020 Edition: 4.0 2020-09
Results: Pass. No degradation of performance was found during test or Lower than limits of measurement.
Test Type: Basic safety and performance requirements for home healthcare environment
Sample Size: The test sample is the final, finished product of representative model: MK66R-B
Standard: IEC 60601-1-11:2015+A1:2020 Edition: 2.0 2020-07
Results: Pass. The device operates normally, and can provide basic safety and essential performance.
Test Type: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Sample Size: The test sample is the final, finished product of representative model: MK66R-B
Standard: IEC 60601-2-57 Edition 1.0 2011-01
Results: Pass. The test result is within the test acceptance range of the standard.
Test Type: Photobiological safety of lamps and lamp systems
Sample Size: The test sample is the final, finished product of representative model: MK66R-B
Standard: IEC 62471 First edition 2006-07
Results: Pass. The test result is within the test acceptance range of the standard.
Test Type: Usability Study
Sample Size: The test sample is the final, finished product of representative model: MK66R-B
Standard: IEC 62366-1 Edition 1.0 2015-02 and IEC 60601-1-6 Edition 3.1 2013-10
Results: Pass. The subject device can meet the usability goal of IEC 62366-1 and IEC 60601-1-6 standards.
Test Type: Shelf Life Test
Sample Size: The test sample is the final, finished product of representative model: MK66R-B
Method: Performance test; Key life test; Mask bending test; Plug and pull test; Power Density Test; Leakage current test.
Results: Pass. Includes: Appearance (no deformation, smooth, no burrs, no color sports, silicone thickness within range), Key life (no stuck, sensitive, normal ON/OFF, LED indicator works), Mask bending (no cracks, no damage, charges and works normally), Plug and pull (charges and works normally, indicator lights up), Power Density (30 mw/cm2 +/- 10%), Leakage current (meets IEC 60601-1 clause 8.7.4).
Clinical Performance:
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 22, 2022
Light Tree Ventures Europe B.V. % Alain Dijkstra Official Correspondent Shenzhen Kaiyan Medical Equipment Co., Ltd Building 3, No.40, Fuxin street, Huaide Community, Fuyong Town, Baoan District Shenzhen, Guangdong 518103 China
Re: K221946
Trade/Device Name: LED Light Therapy Mask (model: MK66R-B) 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 20, 2022 Received: October 20, 2022
Dear Alain Dijkstra:
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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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,
Digitally signed by Yan Yan Fu -S Date: 2022.11.22 11:42:54 -05'00'
For 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
2
Indications for Use
510(k) Number (if known) K221946
Device Name LED Light Therapy Mask (Model: MK66R-B)
Indications for Use (Describe)
The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the 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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3
510(k) Summary of K221946
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information:
Sponsor Name: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com
Manufacturer:
Manufacturer Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building 3, No.40, Fuxin street, Huaide Community, Fuyong Town, Baoan District, Shenzhen, Guangdong, 518103, China Contact Person (including title): Alain Dijkstra (CEO) Tel: 0755-82129361 Fax: 0755-25024651 E-mail: regulation@kaiyanmedical.com
Distributor:
CompanyCurrentBody.com Ltd Add: Unit D6,Stanley Green Business Park,Commercial Avenue,Cheadle Hulme,Cheshire, SK8 6QH
Application Correspondent:
Contact Person: Alain Dijkstra Company: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building 3, No.40, Fuxin street, Huaide Community, Fuyong Town, Baoan District, Shenzhen, Guangdong, 518103, China Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com
Date of the summary prepared: November 20, 2022
2. Subject Device Information
Classification Name: Light based over the counter wrinkle reduction Trade Name: LED LIGHT THERAPY MASK Model Name: MK66R-B Trademark: CurrentBody Skin™ Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CRF 878.4810 Regulatory Class: II
4
3. Predicate Device Information
Sponsor: ISMART Marketing Svcs Ltd Trade Name: FaceLITE Classification Name: Light based over the counter wrinkle reduction 510(K) Number: K191629 Review Panel: General & Plastic Surgery Product Code: OHS Requlation Number: 21 CRF 878.4810 Regulation Class: II
4. Device Description
The LED LIGHT THERAPY MASK is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles.
The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of sillcone.
The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The LED LIGHT THERAPY MASK cannot be operated while charging. The controller switches the LEDs ON/OFF and controls power to the mask. The device does not have an adapter, please use adapters of the following specifications: input: 100-240Va.c., 50Hz/60Hz, output: DC 5V, 2A.
The device produces red and near infra-red (NIR) light in the visible spectrum (Red: 630+/-5nm, NIR: 830nm) in intended to improve the appearance of wrinkles. The controller switches the LEDs ON/OFF and controls power to the mask. And the cable for connecting with the controller is non-detachable.
5. Intended Use / Indications for Use
The LED LIGHT THERAPY MASK (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
6. Comparison to predicate device
Compare with predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | Light Tree Ventures Europe B.V. | ISMART Marketing Svcs Ltd | -- |
| Trade Name | LED LIGHT THERAPY MASK | FaceLITE | -- |
| Classification | |||
| Name | Light Based Over The Counter | ||
| Wrinkle Reduction | Light Based Over The Counter | ||
| Wrinkle Reduction | -- | ||
| 510(k) Number | K221946 | K191629 | -- |
| Product Code | OHS | OHS | Same |
| FDA Device | |||
| Classification | Class II | Class II | Same |
| Use | Over the Counter | Over the counter | Same |
5
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Intended Use / | |||
| Indications for | |||
| Use | The LED LIGHT THERAPY MASK | ||
| (MK66R-B) is an over-the-counter | |||
| device that is intended for the use in | |||
| the treatment of full-face wrinkles. | The faceLITE LED mask is an | ||
| over-the-counter device that is | |||
| intended for the use in the | |||
| treatment of full-face wrinkles. | Same | ||
| Intended location | |||
| of use | Face | Face | Same |
| Energy Type | Light emitting diodes | Light emitting diodes | Same |
| Wavelengths | Red: 630±5 nm | ||
| NIR: 830nm | Red: 630nm±10nm | ||
| NIR: 830nm±10nm | Same | ||
| Total Intensity | |||
| (mW/cm²) | 30mw/cm² | 30mw/cm² total | Same |
| LED number | 630±5nm: 66 | ||
| 830nm: 66 | 630±5nm: 49 | ||
| 830nm: 49 | Different, | ||
| Note | |||
| LED distribution | Uniform distribution | Uniform distribution | Same |
| Power flux | |||
| (mW/cm²) | 630±5nm:15-20 mW/cm² | ||
| 830nm:10-15 mW/cm² | 630±5nm: 15-20 mW/cm² | ||
| 830nm: 6-12 mW/cm² | Similar | ||
| Note | |||
| Treatment Time | 10 minutes | 600 seconds | Same |
| Dose | 540 J/cm2 (cumulative does) | 540 J/cm2 (cumulative does) | Same |
| Treatment | |||
| protocol | 5 x weekly, 6 weeks | 5 x weekly, 6 weeks | Same |
| Software | |||
| controller | Device uses a timer and software to | ||
| control treatment duration | Yes | Same | |
| Power supply | Rechargeable Lithium battery | Rechargeable Lithium battery | Same |
Comparison in Detail(s):
Note: Although the "LED number" and "Power flux" is a little different from the predicate devices, both of them have the same out wavelengths, total Intensity, treatment time and dose, and they all complied with the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57 and IEC 62471 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues.
7. Test Summary
7.1 Summary of Non-Clinical Performance Testing
LED LIGHT THERAPY MASK (Model: MK66R-B) has been evaluated the safety and performance by lab bench testing as following:
| Title of the test | Device
Description/Sample Size | Test
Standards | Method/Applicable
Acceptance criteria | Unexpected
Results/Significant
Deviations | Test
results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-----------------|
| General
requirements
for basic
safety and | The test
sample is the
final, finished
product of | IEC 60601-
1:2005+A1:2012+A2:2020 Edition: 3.2 2020-08 | The test is carried out
under the test method
specified in the
standard, and the test | NA | Pass |
| essential
performance | representativ
e model:
MK66R-B | | result is within the test
acceptance range of
the standard. | | |
| Location:
VOL_010_A8.
Electrical
Safety and
EMC_
001_A8-1. IEC
60601-1, IEC
60601-1-11
Test Report
Electromagneti
c disturbances | The test
sample is the
final, finished
product of
representativ
e model:
MK66R-B | IEC 60601-1-
2:2014+A1:2020 Edition:
4.0 2020-09 | No degradation of
performance was
found during test or
Lower than limits of
measurement. | NA | Pass |
| Location:
VOL_010_A8.
Electrical
Safety and
EMC_
004_A8-4. IEC
60601-1-2 Test
Report | The test
sample is the
final, finished
product of
representativ
e model:
MK66R-B | IEC 60601-1-
2:2014+A1:2020 Edition:
4.0 2020-09 | No degradation of
performance was
found during test or
Lower than limits of
measurement. | NA | Pass |
| Basic safety
and
performance
requirements
for home
healthcare
environment
Location:
VOL_010_A8.
Electrical
Safety and
EMC_
001_A8-1. IEC
60601-1, IEC
60601-1-11
Test Report | The test
sample is the
final, finished
product of
representativ
e model:
MK66R-B | IEC 60601-1-
11:2015+A1:2020 Edition:
2.0 2020-07 | The device operates
normally, and can
provide basic safety
and essential
performance. | NA | Pass |
| Particular
requirements
for the basic
safety and
essential
performance
of non-laser | The test
sample is the
final, finished
product of
representativ
e model:
MK66R-B | IEC 60601-2-57 Edition
1.0 2011-01 | The test is carried out
under the test method
specified in the
standard, and the test
result is within the test
acceptance range of
the standard. | NA | Pass |
| light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Location:
VOL_010_A8.
Electrical Safety and EMC_
002_A8-2. IEC 60601-2-57
Test Report | | | | | |
| Photobiological safety of lamps and lamp systems
Location:
VOL_010_A8.
Electrical Safety and EMC_
003_A8-3. IEC 62471 Test Report | The test sample is the final, finished product of representativ
e model:
MK66R-B | IEC 62471 First edition 2006-07 | The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. | NA | Pass |
| Usability Study
Location:
VOL_009_A7.
Usability | The test sample is the final, finished product of representativ
e model:
MK66R-B | IEC 62366-1 Edition 1.0 2015-02 and IEC 60601-1-6 Edition 3.1 2013-10 | The subject device can meet the usability goal of IEC 62366-1 and IEC 60601-1-6 standards. | NA | Pass |
| Shelf Life Test | The test sample is the final, finished product of representativ
e model:
MK66R-B | The Shelf Life Test Report performs the following tests on the product before and after accelerated aging, and after use:
Performance test;
Key life test;
Mask bending test;
Plug and pull test; | Performance Test:
● Appearance:
The device should be no deformation, the surface is smooth and free of burrs, no color sports.
● The silicone | NA | Pass |
6
7
8
| | Plug and pull test;
Power Density Test;
Leakage current test; | thickness is 9.42 $\pm$ 0.1 mm on
point A, 5 $\pm$ 0.1
mm on point B. |
|--|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Key life test: |
| | | There should be no key stuck. The key is sensitive. The device can be turned on and off normally. The LED indicator can work normally when pressing the key. |
| | | Mask bending test: |
| | | The device should be no cracks, no damage, can be charged and work normally. |
| | | Plug and pull test: |
| | | The device can be charged and work normally: The indicator can light up normally when plug the adapter into the power outlet. |
| | | Power Density Test: |
| | | Power Density: 30 mw/cm2 $\pm$ 10% (27 - 33 mw/cm2); |
| | | Leakage current test: |
| | | Should meet the clause 8.7.4 of IEC 60601-1 required. |
1) Biocompatibility statement
The component materials for Velcro Straps of the LED LIGHT THERAPY MASK (Models: MK66R-B) is identical to the corresponding component for Velcro Straps of the Aduro Light Beauty Mask (MK-660, MK-66USBO, MK-66USBA, MK-66USBB, MK-02O, MK-02B) in formulation, processing,
9
sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents), that manufactured by SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD and has been clarified in K202390 on July 14, 2021.
The patient contacting material silicone of the outer surface and inner surface of model MK66R-B is identical to the materials for Aduro Light Beauty Mask (Model: MK-660, MK-66USBA, MK-66USBB, MK-020, MK-02B) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold release agents), that manufactured by SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD and has been clarified in K202390 on July 14, 2021.
2) Usability Testing
Usability testing was conducted on the LED LIGHT THERAPY MASK (Model: MK66R-B), which complies with IEC 62366-1 and IEC 60601-1-6.
3) Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
7.2 Summary of Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
8. Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K191629.