(87 days)
No
The device description focuses on the physical components and light wavelengths, with no mention of AI or ML capabilities. The summary explicitly states the device is not used to make measurements or draw conclusions, which are common applications of AI/ML in medical devices.
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 and 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's a therapeutic device, not a diagnostic one.
No
The device description clearly outlines a physical hardware device (mask, controller, battery, power supply) that emits light for therapeutic purposes. While it mentions software verification and validation, this is for the control of the hardware, not the device itself being solely software.
Based on the provided information, 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." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description focuses on the mechanism of action (light wavelengths stimulating skin rejuvenation) and the physical characteristics of the device. It explicitly states, "The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat."
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on safety, electrical standards, biocompatibility, usability, and software validation. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) 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 HigherDose Red and Infrared Light Mask is a home wearable light-emitting diode phototherapy device with two proven wavelengths of light 630nm and 830nm(near infrared light ) for treatment of fullface wrinkles,
The face mask combine Red (630nm)and near infrared light (830nm).Harnessed at the perfect measurement to rejuvenate the skin, these two wavelengths work below the skin's surface to stimulate the natural rejuvenation process ,creating a complexion that is visibly growing and noticeably healthier looking.
The mask is worn on the face and is held in place by head 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 HIGHERDOSE Red And Infrared Light 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
full-face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Performance Testing
1) Performance Testing Summary
The HIGHERDOSE Red And Infrared Light Mask (Model: MK-66L) has been evaluated the safety and performance by lab bench testing as following:
- General requirements for basic safety and essential performance: The test sample is the final, finished product. Tested with IEC 60601-1:2005/AMD 1:2012/AMD 2:2020. Acceptance criteria: 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. Result: Pass.
- Electromagnetic disturbances: The test sample is the final, finished product. Tested with IEC 60601-1-2:2014+A1:2020. Acceptance criteria: No degradation of performance was found during test or Lower than limits of measurement. Result: Pass.
- Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment: The test sample is the final finished product. Tested with IEC 60601-1-11:2015/AMD1:2020. Acceptance criteria: The device operates normally and can provide basic safety and essential performance. Result: Pass.
- Particular Requirements for The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use: The test sample is the final, finished product. Tested with IEC 60601-2-57:2011. Acceptance criteria: 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. Result: Pass.
- Photobiological safety of lamps and lamp systems: The test sample is the final, finished product. Tested with IEC 62471:2006. Acceptance criteria: 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. Result: Pass.
- Shelf Life Test: The test sample is the final, finished product. Tested with 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. Acceptance criteria: The device can meet the requirement of the performance test, Power Density test and Leakage current test. Result: Pass.
2) Biocompatibility testing
The component materials of the subject device are identical to the corresponding component materials of the previously cleared devices ( K202390) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents).
Here is no change in biocompatibility since the previously cleared devices. Therefore, based on this information, the subject device can comply with the biocompatibility requirements of ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-10 (Irritation).
3) Usability Testing
Usability testing was conducted on the HIGHERDOSE Red And Infrared Light Mask, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K221775, K214103, K191629, K202390
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2024
Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra Regulatory Affairs Engineer Building #3 and Building #5, 40th of Fuxin Street Huaide Community Fuyong Town, Baoan District Shenzhen, Guangdong 518103 China
Re: K241933
Trade/Device Name: HIGHERDOSE Red and Infrared Light Mask (MK66-L) 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: June 12, 2024 Received: July 2, 2024
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 (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/ofdocs/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
K241933 - Alain Dijkstra
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 OS 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 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).
2
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-devices/deviceadvice-comprehensive-regulatory-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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE - ○ Date: 2024.09.27
23:22:48 -04'00'
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
HIGHERDOSE RED AND INFRARED LIGHT MASK (MK66-L)
Indications for Use (Describe)
The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
K241933
510(k) Summary
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: SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD Establishment Registration Number: 3011644607 Address: Building #3, and Building#5 40th of Fuxin street, Huaide Community, Fuyong Town, Baoan District, Shenzhen, Guangdong, 518103, China Contact Person (including title): Alain Dijkstra Tel: +86 755 82129361 Fax: +86 755 25024651 E-mail: alaindijkstra@kaiyanmedical.com
Distributor
Company Name: HIGHERDOSE LLC Address: 42 Broadway, 12th Floor, #212, NewYork, NY 10004 Establishment Registration Number: 3019734322 Contact Person: Sumish Khadka E-mail: sumish@higherdose.com
Manufacturer:
Manufacturer Name: SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD Address: Building #3, and Building#5 40th of Fuxin street, Huaide Community, Fuyong Town, Baoan District, Shenzhen, Guangdong, 518103, China Contact Person (including title): Alain Dijkstra Tel: +86 755 82129361 Fax: +86 755 25024651 E-mail: alaindijkstra@kaiyanmedical.com
Application Correspondent:
Contact Person: Alain Dijkstra Company: SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD Address: Building #3, and Building#5 40th of Fuxin street, Huaide Community, Fuyong Town, Baoan District, Shenzhen, Guangdong, 518103, China Tel: +86 755 82129361
5
Fax: +86 755 25024651 E-mail: regulation@kaiyanmedical.com
2. Date of the summary prepared: September 26, 2024
3.Subject Device Information
Classification Name: Light Based Over-The Counter Wrinkle Reduction (OHS) Trade Name: HIGHERDOSE Red And Infrared Light Mask Model Name: MK66-L Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 878.4810 Regulatory Class: II
4. Predicate Device Information
Predicate Device 1 Information
Sponsor: Light Tree Ventures Europe B.V Trade Name: LED Light Therapy Mask Classification Name: Light based over the counter wrinkle reduction 510(K) Number: K221775 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Requlation Class: II
Predicate Device 2 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 3 Information
Sponsor: ISMART Marketing Svcs Ltd Trade Name: FaceLITE
6
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
Predicate Device 4 Information
Sponsor: SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD Trade Name: Aduro Light Beauty Mask Classification Name: Light based over the counter wrinkle reduction 510(K) Number: K202390 Review Panel: General & Plastic Surgery Product Code: OHS,OLP Regulation Number: 878.4810 Requlation Class: II
5. Device Description
The HigherDose Red and Infrared Light Mask is a home wearable light-emitting diode phototherapy device with two proven wavelengths of light 630nm and 830nm(near infrared light ) for treatment of fullface wrinkles,
The face mask combine Red (630nm)and near infrared light (830nm).Harnessed at the perfect measurement to rejuvenate the skin, these two wavelengths work below the skin's surface to stimulate the natural rejuvenation process ,creating a complexion that is visibly growing and noticeably healthier looking.
The mask is worn on the face and is held in place by head 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 HIGHERDOSE Red And Infrared Light 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.
7
6. Intended Use / Indications for Use
For MK-66L
The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
7. Comparison to predicate device and conclusion
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 | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3 | Predicate
Device 4 | Remark |
|---------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Company | HigherDOSE LLC | Light Tree
Ventures
Europe B.V. | Harpar Grace
International | ISMART
Marketing
Svcs Ltd | Shenzhen Kaiyan
Medical
Equipment Co.,
Ltd | -- |
| Trade Name | HigherDose Light
Face Mask | LED Light
Therapy
Mask | Shani Darden
LED light
therapy mask | FaceLITE | Aduro Light
Beauty Mask | -- |
| Classification
Name | Light Based Over
The Counter
Wrinkle
Reduction | Light Based
Over The
Counter
Wrinkle
Reduction | Over-the-
counter
powered light
based laser
for acne | Light Based
Over The
Counter
Wrinkle
Reduction | Light Based
Over-The-Counter
Wrinkle Reduction | -- |
| 510(k)
Number | TBD | K221775 | K214103 | K191629 | K202390 | -- |
| Product
Code | OHS | OHS, OLP | OHS, OLP | OHS | OHS,OLP | Same |
| FDA Device
Classification | Class II | Class II | Class II | Class II | Class II | Same |
| Use | Over the Counter | Over the
Counter | Over the
counter | Over the
counter | Over the counter | Same |
| Intended
Use /
Indications
for Use | The
HIGHERDOSE
Red And Infrared
Light Mask
(Model: MK66-L)
is an over the | The LED
Light Therapy
Mask
(Models: MK-
78, MK-04) is
an over the | The Shani
Darden LED
light therapy
mask is an
over-the-
counter | The faceLITE
LED mask is
an over the
counter device
that is
intended for | The Aduro Light
Beauty Mask
(Model: MK-660,
MK-66USBO, MK-
020) emits energy
in the red and
blue region of the
spectrum, | Same |
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3 | Predicate
Device 4 | Remark |
| | counter device
that is intended for
the use in the
treatment of full-
face wrinkles. | counter
device that is
intended for
the use in the
treatment of
full-face
wrinkles. | 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
spectrum and
is intended for
the use in the
treatment of
full-face
wrinkles. | the use in the
treatment of
full-face
wrinkles. | indicated to treat
full face wrinkles
and/or mild to
moderate acne. | |
| | | 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, | | | | |
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3 | Predicate
Device 4 | Remark |
| | | 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. | | | | |
| Intended
location of
use | Face | Face | Face | Face | Face | same |
| Energy Type | Light emitting
diodes | Light emitting
diodes | Light emitting
diodes | Light emitting
diodes | Light emitting
diodes | Same |
| Wavelengths | Red:
630nm±10nm
NIR:
830nm±10nm | 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 | Red:640nm±10nm
Blue:465nm±10nm | Same |
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3 | Predicate
Device 4 | Remark |
| Total
Intensity
(mW/cm²) | Red 20mw/cm²,
Infrared Red :
30mw/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
Red/NIR 29
mW/cm² | 30mw/cm²
total | 30mw/cm² | same |
| | | Treatment
Time | 10 minutes | 10 minutes | 10 minutes | 600 seconds |
| Dose | Red 12, Infrared
Red: 18 J/cm² | 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) | | Same |
| | | Treatment
protocol | 3-5 times /week | 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 |
| Software
controller | Device uses a
timer and software | Device uses
a timer and | Device uses a
timer and | Yes | Device uses a
timer and software | Same |
| Elements of
Comparison | Subject Device | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3 | Predicate
Device 4 | Remark |
| | to control
treatment duration | software to
control
treatment
duration | software to
control
treatment
duration | | to control
treatment duration | |
| Power
supply | Rechargeable
Lithium battery | Rechargeable
Lithium
battery | 100-240V | Rechargeable
Lithium battery | Rechargeable
Lithium battery | Same |
8
9
10
11
Final Conclusion:
The subject device is the same or similar to the legally marketed predicate device K221775, K214103, K191629 and K202390.
8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
1) Performance Testing Summary
The HIGHERDOSE Red And Infrared Light Mask (Model: MK-66L) 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,
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 | The
test
sample is
the
final | IEC 60601-
1-
11:2015/AM | The
device
operates
normally and | NA | Pass |
| equipment and
medical
electrical
systems used in
the home
healthcare
environment. | finished
product. | D1:2020 | can provide
basic safety
and essential
performance. | | |
| Particular
Requirements
for The Basic
Safety And
Essential
Performance Of
Non-Laser Light
Source
Equipment
Intended For
Therapeutic,
Diagnostic,
Monitoring And
Cosmetic/Aesth
etic Use | 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
standard, and
the test result is
within the test
acceptance
range of the
standard. | NA | Pass |
| 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 |
12
13
2) Biocompatibility testing
The component materials of the subject device are identical to the corresponding component materials of the previously cleared devices ( K202390) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents).
Here is no change in biocompatibility since the previously cleared devices. Therefore, based on this information, the subject device can comply with the biocompatibility requirements of ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-10 (Irritation).
3) Usability Testing
Usability testing was conducted on the HIGHERDOSE Red And Infrared Light Mask, 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 K221775, K214103, K191629 and K202390.