(182 days)
Not Found
No
The device description focuses on the hardware components (LEDs, controller, battery) and the mechanism of action (emitting light at specific wavelengths). There is no mention of any software or algorithms that would suggest the use of AI or ML for analysis, decision-making, or personalized treatment. The device simply switches LEDs on/off and controls power/modes.
Yes
The device is intended for the treatment of full-face wrinkles and mild to moderate acne vulgaris, which are medical conditions that are addressed by therapeutic devices.
No
Explanation: The device is intended for treatment (full-face wrinkles and acne vulgaris) by emitting light, and the text explicitly states, "The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat." This indicates it is not a diagnostic device.
No
The device description clearly outlines hardware components including a flexible silicone mask with LEDs, a controller with a rechargeable battery, a power supply, and adjustable Velcro straps. The performance studies also include testing related to hardware standards (IEC 60601 series).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face. IVDs are used for the diagnosis or monitoring of diseases or conditions by examining specimens from the human body.
- Device Description: The device emits light to treat conditions. It does not analyze biological samples or provide diagnostic information.
- Lack of Diagnostic Function: The text explicitly states, "The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat." This is a key characteristic that differentiates it from an IVD.
Therefore, the LED Light Therapy Mask described is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For MK-78, MK-04,
The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
For MK66-H, EL00003
The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the treatment of full-face wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
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, or mild to moderate acne vulgaris of the face.
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 adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone.
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 device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.
Models MK-78, and MK-04 produce 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. For MK-04, the cable for connecting with the controller is nondetachable, but the cable is detachable for MK-78. Model MK-04 contains many rose quartz crystals in inner surface for decoration purpose, the crystals do not contact with skin and there is no therapeutic effect.
Model MK66-H and EL00003 produce blue, red, and near infra-red (NIR) light in the visible spectrum (Blue: 415nm, Red: 630+/- 5nm, NIR: 830nm). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller switches the LEDs ON/OFF, controls power to the mask, and switches treatment modes. The cable for connecting with the controller is detachable. Both MK66-H and EL00003 have two pieces of removable eye protection which are for protect eyes from the light.
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
Over the Counter
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)
Summary of Non-Clinical Performance Testing
- Performance Testing Summary: The LED Light Therapy Mask (Model: MK-78, MK-04, MK66-H, EL00003) has been evaluated the safety and performance by lab bench testing according to IEC 60601-1:2005/AMD 1:2012/AMD 2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-2-57:2011, IEC 62471:2006, and Shelf Life Test. All tests were passed.
- Biocompatibility testing: ISO 10993-1: 2018, EN ISO 10993-5:2009, EN ISO 10993-10:2010 were conducted.
- Usability Testing: Usability testing was conducted on the LED Light Therapy Mask (Model: MK-78, MK-04, MK66-H, EL00003), the device complies with IEC 62366-1 and IEC 60601-1-6.
- 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.
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 (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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo 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.
December 20, 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: K221775
Trade/Device Name: LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, EL00003) 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: October 21, 2022 Received: October 21, 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 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
2
Indications for Use
510(k) Number (if known) K221775
Device Name
LED Light Therapy Mask (Model: MK-78, MK-04, MK66-H, EL00003)
Indications for Use (Describe)
For MK-78, MK-04,
The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
For MK66-H, EL00003
The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended 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
510(k) Summary for K221775
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: alaindijkstra@kaiyanmedical.com
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
2. Date of the summary prepared: December 19, 2022
3. Subject Device Information
Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS)
4
Trade Name: LED Light Therapy Mask Model Name: MK-78, MK-04, MK66-H, EL00003 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulatory Class: II
4. Predicate Device Information
Predicate Device 1 Information
Sponsor: Harpar Grace International Trade Name: Shani Darden LED light therapy mask Classification Name: Over-the-counter powered light based laser for acne 510(K) Number: K214103 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulation Class: II
Predicate Device 2 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 Regulation Number: 878.4810 Regulation Class: II
5. 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, or mild to moderate acne vulgaris of the face.
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 adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone.
5
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 device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.
Models MK-78, and MK-04 produce 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. For MK-04, the cable for connecting with the controller is nondetachable, but the cable is detachable for MK-78. Model MK-04 contains many rose quartz crystals in inner surface for decoration purpose, the crystals do not contact with skin and there is no therapeutic effect.
Model MK66-H and EL00003 produce blue, red, and near infra-red (NIR) light in the visible spectrum (Blue: 415nm, Red: 630+/- 5nm, NIR: 830nm). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller switches the LEDs ON/OFF, controls power to the mask, and switches treatment modes. The cable for connecting with the controller is detachable. Both MK66-H and EL00003 have two pieces of removable eye protection which are for protect eyes from the light.
6. Intended Use / Indications for Use
For MK-78, MK-04
The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
For MK66-H, EL00003
The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
7. Comparison to predicate device and conclusion
6
Compare with predicate device, 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 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Company | Light Tree Ventures | |||
| Europe B.V. | Harpar Grace | |||
| International | ISMART Marketing | |||
| Svcs Ltd | -- | |||
| Trade Name | LED Light Therapy | |||
| Mask | Shani Darden LED | |||
| light therapy mask | FaceLITE | -- | ||
| Classification | ||||
| Name | Light Based Over The | |||
| Counter Wrinkle | ||||
| Reduction | Over-the-counter | |||
| powered light based | ||||
| laser for acne | Light Based Over The | |||
| Counter Wrinkle | ||||
| Reduction | -- | |||
| 510(k) Number | K221775 | K214103 | K191629 | -- |
| Product Code | OHS, OLP | OHS, OLP | OHS | Same |
| FDA Device | ||||
| Classification | Class II | Class II | Class II | Same |
| Use | Over the Counter | Over the counter | Over the counter | Same |
| Intended Use / | ||||
| Indications for | ||||
| Use | The LED Light Therapy | |||
| Mask (Models: MK-78, | ||||
| MK-04) is an over the | ||||
| counter device that is | ||||
| intended for the use in | ||||
| the treatment of full-face | ||||
| wrinkles. |
The LED Light Therapy
Mask (Models: MK66-H,
EL00003) is an over the
counter device intended
to emit energy in the red
and blue region of the
light spectrum,
specifically indicated to
treat mild to moderate
acne vulgaris of the | The Shani Darden
LED light therapy
mask is an over-the-
counter device
intended to emit
energy in the red and
blue region of the light
spectrum, specifically
indicated to treat mild
to moderate acne
vulgaris of the face.
The Shani Darden
LED light therapy
mask is an over-the-
counter device
intended to emit
energy in the red and
Near Infra-red | The faceLITE LED
mask is an over the
counter device that is
intended for the use in
the treatment of full-
face wrinkles. | Same |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| | face.
The LED Light Therapy
Mask (Models: MK66-H,
EL00003) is an over the
counter device intended
to emit energy in the red
and Near Infra-red
spectrum and is
intended for the use in
the treatment of full-face
wrinkles. | spectrum and is
intended for the use in
the treatment of full-
face wrinkles. | | |
| Intended
location of use | Face | Face | Face | Same |
| Energy Type | Light emitting diodes | Light emitting diodes | Light emitting diodes | Same |
| Wavelengths | 1.MK-78, MK-04:
Red: 630±5 nm
NIR: 830nm
2.MK66-H, EL00003:
Blue: 415nm,
Red: 630nm +/- 5nm,
NIR: 830nm | Blue: 415nm +/-
10nm,
Red: 630nm +/- 10nm,
NIR: 830nm +/-10nm. | Red: 630nm±10nm
NIR: 830nm±10nm | Same |
| Total Intensity
(mW/cm²) | 1.MK-78: 20-30 mw/cm²
2.MK-04: 30mw/cm²
3.MK66-H, EL00003:
(1)Blue/Red 44 mw/cm²
(2)Red/NIR 30 mw/cm² | Blue/Red 44 mW/cm² | 30mw/cm² total | Similar
Note 1 |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| | | Red/NIR 29 mW/cm² | | |
| Treatment Time | 10 minutes | 10 minutes | 600 seconds | Same |
| Dose | 1.MK-78: 12-18 J/cm²
2.MK-04: 18 J/cm²
3.MK66-H, EL00003:
(1)Blue/Red: 26.4 J/cm²
(2)Red/NIR: 18 J/cm² | Blue 16.8 J/cm²
Red 9.6 J/cm²
Red 11 J/cm²
NIR 7 J/cm² | 540 J/cm² (cumulative
does) | Similar
Note 2 |
| Treatment
protocol | Acne: 4 x weekly, 6
weeks;
Wrinkles: 5 x weekly, 6
weeks | Acne: 4 x weekly, 6
weeks;
Wrinkles: 5 x weekly,
6 weeks. | 5 x weekly, 6 weeks | Same |
| Software
controller | Device uses a timer and
software to control
treatment duration | Device uses a timer
and software to
control treatment
duration | Yes | Same |
| Power supply | Rechargeable Lithium
battery | 100-240V | Rechargeable Lithium
battery | Same |
7
8
Comparison in Detail(s):
Note 1:
Though there is a minor difference of the "Total Intensity" between the subject and predicate devices, the device passed the testing according to IEC 60601-2-57, such a minor deviation would not affect safety and effectiveness.
Note 2:
The dose of the subject device is a single treatment dose calculated based on the total intensity, but the cumulative dose of MK-78, and MK-04 will be equal to the predicate device K191629. And the dose of
9
MK66-H and EL00003 will be almost the same as the predicate device K214103 when the dose of K214103 is calculated according to the total intensity. And the subject device passed the testing according to IEC60601-2-57, so such a minor deviation would not affect safety and effectiveness.
8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
1) Performance Testing Summary
The LED Light Therapy Mask (Model: MK-78, MK-04, MK66-H, EL00003) has been evaluated the safety and performance by lab bench testing as following:
| Title of the test | Device
Description
/Sample
Size | Test
Method/Ap
plicable
Standards | Acceptance
criteria | Unexpec
ted
Results/
Significa
nt
Deviatio
ns | Test
results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------|
| General
requirements for
basic safety and
essential
performance | The test
sample is
the final,
finished
product. | IEC 60601-
1:2005/AMD
1:2012/AMD
2:2020 | 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 |
| Electromagnetic
disturbances | The
test
sample is
the
final,
the
finished
product. | IEC 60601-
1-
2:2014+A1:
2020 | No degradation
of performance
was
found
during test or
Lower
than
limits
of
measurement | NA | Pass |
| Requirements
for medical
electrical
equipment and
medical
electrical
systems used in
the home
healthcare
environment. | The
test
sample is
the
final,
finished
product. | IEC 60601-
1-
11:2015/AM
D1:2020 | The
device
operates
normally,
and
can provide
basic
safety
and essential
performance. | NA | Pass |
| Particular
Requirements
for The Basic
Safety
And
Essential | The
test
sample is
the
final,
finished
product. | IEC 60601-
2-57:2011 | The
test is
carried
out
under the test
method
specified in the | NA | Pass |
| Performance Of
Non-Laser Light
Source
Equipment
Intended For
Therapeutic,
Diagnostic,
Monitoring And
Cosmetic/Aesth
etic Use | | | standard, and
the test result is
within the test
acceptance
range of the
standard. | | |
| Photobiological
safety of lamps
and
lamp
systems. | The
test
sample is
the final,
finished
product. | IEC
62471:2006 | 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 |
| Shelf Life Test | The
test
sample is
the final,
finished
product. | The Shelf Life
Test Report
performs the
following tests
on the product
before and
after
accelerated
aging, and
after use:
Performance
test;
Power Density
Test;
Leakage
current test. | The device can
meet the
requirement of the
performance test,
Power Density
test and Leakage
current test. | NA | Pass |
10
2) Biocompatibility testing
- ISO 10993-1: 2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a . risk management.
- EN ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- . EN ISO 10993-10:2010 ISO 10993-10 Third Edition 2010 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
11
3) Usability Testing
Usability testing was conducted on the LED Light Therapy Mask (Model: MK-78, MK-04, MK66-H, EL00003), the device complies with IEC 62366-1 and IEC 60601-1-6.
4) 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.
8.2 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.
9. Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K191629 and K214103.