(103 days)
There are no reference devices mentioned in the provided text.
No
The summary describes a simple LED phototherapy device with a fixed treatment program and no mention of adaptive or learning capabilities. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes.
The device is intended to treat Androgenetic Alopecia and promote hair growth, which are medical conditions, thus classifying it as a therapeutic device.
No
The device is a phototherapy device used for treatment, specifically for androgenetic alopecia and promoting hair growth. It is explicitly stated that "The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat." This indicates it does not diagnose.
No
The device description explicitly states it is a "home wearable light-emitting diode phototherapy device" and details hardware components like LEDs, a controller, a power cable, and a rechargeable battery. While software verification and validation were performed, the device is fundamentally a hardware device with embedded software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The HIGHERDOSE Red Light Hat is a phototherapy device that applies light directly to the scalp to treat hair loss. It does not analyze any biological samples.
- Intended Use: The intended use is to treat Androgenetic Alopecia and promote hair growth, which is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and how the light is delivered, not on any analytical or testing capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, making measurements of biological markers, or providing diagnostic information.
Therefore, the HIGHERDOSE Red Light Hat falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types 1 - 1V.
Product codes
OAP
Device Description
The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Nowood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
The device is designed as wearable product, and it consists of the main unit, the controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery.
The hat compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of cotton.
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 Light Hat cannot be operated while charging. The controller switches the LEDs ON/OFF. Switch the controller ON and allow the hat to run for 10 minutes treatment program. The cable for connecting with the controller is detachable.
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
scalp
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
Safety and Performance Test: The HIGHERDOSE Red Light Hat has been evaluated the safety and performance by lab bench testing according to IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV (include IEC 60601-1-6:2010+A1:2013+A2:2020 ), IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-2-57:2023, and IEC 62471:2006. All tests were passed.
Usability Test: Usability testing was conducted on the HIGHERDOSE Red Light Hat (Model: HG-120K), and 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 "Content of Premarket Submissions for Device Software Functions -Guidance for Industry and Food and Drug Administration Staff."
Cybersecurity: The subject device has no external interfaces, so no cybersecurity evaluation was needed.
Biocompatibility testing: The component materials of the subject device are identical to previously cleared devices (K223893) in formulation, processing, sterilization, and geometry, with no added chemicals. Based on this, the subject device complies with biocompatibility requirements of ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-23 (Irritation).
Clinical Performance: Clinical testing was not needed for this 510(k), as the non-clinical performance testing was sufficient.
Key Metrics
Not Found
Predicate Device(s)
K211038, K193008, K173729, K213025
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."
November 20, 2024
Shenzhen Kaiyan Medical Equipment Co., Ltd % Mary Kaps Higherdose LLC 42 Broadwav, 12th Floor, #212 New York, New York 10004
Re: K242363
Trade/Device Name: HIGHERDOSE Red Light Hat (HG-120K) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: July 17, 2024 Received: August 9, 2024
Dear Mary Kaps:
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 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
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 comprehensiveregulatory 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,
TANISHA TANISHA L. HITHE -TANISHA L. HITHE -S L. HITEE -S Date: 2024.11.20
13:11:19 -05'00'
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
Submission Number (if known)
Device Name
HIGHERDOSE RED LIGHT HAT (HG-120K)
Indications for Use (Describe)
The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classfications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types 1 - 1V.
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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K242363
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, No.40, Fuxin Street, Huaide Community, Fuyong Town, Baoan District, Shenzhen, Guangdong, 518103, China Contact Person (including title): Alain Dijkstra (CEO) 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, 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
5
Fax: +86 755 25024651 Email: registrar@kaiyanmedical.com
2. Date of the summary prepared: August 26, 2024 3.Subject Device Information Classification Name: Infrared Lamp Trade Name: HIGHERDOSE Red Light Hat Model Name: HG-120K Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulatory Class: II
4. Predicate Device Information
Predicate Device 1 Information Sponsor: Biophotas Inc Trade Name: Biophotas Celluma RESTORE Classification Name: Infrared Lamp 510(K) Number: K211038 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: II
Predicate Device 2 Information
Sponsor: ADVIHAIR S.R.L. Trade Name: Tricoglam Home Use Classification Name: Infrared Lamp 510(K) Number: K193008 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: II
Predicate Device 3 Information
Sponsor: PhotonMD, Inc Trade Name: Revian Red
6
Classification Name: Infrared Lamp
510(K) Number: K173729 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: II
Predicate Device 4 Information
Sponsor: Kam Yuen Plastic Products Ltd. Trade Name: Laser hair growth helmet Classification Name: Infrared Lamp 510(K) Number: K213025 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: II
5. Device Description
The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Nowood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
The device is designed as wearable product, and it consists of the main unit, the controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery.
The hat compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of cotton.
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 Light Hat cannot be operated while charging. The controller switches the LEDs ON/OFF. Switch the controller ON and allow the hat to run for 10 minutes treatment program. The cable for connecting with the controller is detachable.
7
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.
6. Intended Use / Indications for Use
The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
8
7. Comparison to predicate device and conclusion
Compare with predicate device, the subject is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device do not raise and new questions of safety or effectiveness.
| Elements of
Comparison | Subject Device | Predicate
Device1 | Predicate Device
2 | Predicate Device
3 | Predicate Device
4 | Remark |
|------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| | Company | Shenzhen Kaiyan
Medical
Equipment Co,.
Ltd | Biophotas Inc | ADVIHAIR S.R.L. | PhotonMD, Inc | Kam Yuen Plastic
Products Ltd. |
| Trade Name | HIGHERDOSE
Red Light Hat | Biophotas
Celluma
RESTORE | Tricoglam Home
Use | Revian Red | Laser hair growth
helmet | – |
| Classification
Name | Laser, Comb, Hair | Laser, Comb, Hair | Laser, Comb, Hair | Laser, Comb, Hair | Laser, Comb, Hair | – |
| 510(k) Number | TBD | K211038 | K193008 | K173729 | K213025 | – |
| Product Code | OAP | OAP | OAP | OAP | OAP | Same |
| FDA Device
Classification | Class II | Class II | Class II | Class II | Class II | Same |
| Use | Over the Counter | Over the Counter | Prescription, Rx | Over the counter | Over the counter | Same |
| Intended Use /
Indications for
Use | The
HIGHERDOSE
Red Light Hat is
used to treat
Androgenetic
Alopecia and | The BioPhotas
Celluma
RESTORE is
indicated to treat
Androgenetic
Alopecia and
promote hair
growth in males
who have
Norwood- | Tricoglam Home
Use is indicated
to promote hair
growth in females
with and rogenetic
alopecia who | The REVIAN RED
device is
indicated to treat
Androgenetic
Alopecia and to
Promote Hair | The Laser hair
growth helmet
(Model: A-800) is
intended for the
promotion of hair
growth in females | Same |
| | promote hair | Hamilton | have LudwigSavin | Growth in males | with androgenic | |
| | growth in males | Classifications of
Ila - V | Classification s I - | who have | alopecia who | |
| | who have | patterns of hair | II, in males with | Norwood- | have LudwigSavin | |
| | Norwood- | loss and to treat | androgenetic | Hamilton | Classifications I-II, | |
| | Hamilton | Androgenetic | alopecia who | Classifications of | and in males with | |
| | Classifications of | Alopecia and | have Norwood | Ila - V patterns of | androgenetic | |
| | Ila - V patterns of | promote hair | Hamilton | hair loss and to | alopecia who | |
| | hair loss and to | growth in females | Classification s Ila | treat | have Norwood | |
| | treat | who have | - V and for both, | Androgenetic | Hamilton | |
| | Androgenetic | LudwigSavin | Fitzpatrick | Alopecia and | Classifications Ila- | |
| | Alopecia and | Scale I-1 to I-4, II- | Classification of | Promote Hair | V; and both | |
| | promote hair | 1, II-2 or frontal | Skin Phototypes | Growth in females | genders having | |
| | growth in females | patterns of hair | of I - IV. | who have | Fitzpatrick | |
| | who have Ludwig- | loss; both with | | LudwigSavin | Classification of | |
| | Savin Scale I-1 to | Fitzpatrick | | Scale I-1 to I-4, II | Skin Phototypes I- | |
| | l-4, II-1, II-2 or | SkinTypes I - IV. | | -1, II2 or frontal | IV | |
| | frontal patterns of | | | patterns of hair | | |
| | hair loss; both | | | loss; both with | | |
| | with Fitzpatrick | | | Fitzpatrick Skin | | |
| | Skin Types I - IV. | | | Types I - IV. | | |
| Intended | | | | | | |
| location of use | scalp | scalp | scalp | scalp | scalp | Same |
| | Light emitting | Light emitting | Light emitting | Light emitting | | |
| Energy Type | diodes | diodes | diodes | diodes | LLLT | Same |
| Wavelengths | Red: 650nm+/-
10nm | Red: 640nm+/-
25nm
(615-665nm) | 650 nm +/-10nm | 620-660 nm | 650nm±10nm | Similar
Note1 |
| Total Intensity
(mW/cm2) | 5 mW/cm² | 2.77 mW/cm² | 525 mW | Not available | 2.02 mW/cm² | Similar
Note2 |
| Treatment Time | 10 minutes | 30 min | 20 minutes in
continuous every
day | Every day 10
mins | Each Treatment:
25 min | Similar
Note3 |
| Dose | Red: 3J/cm² | 4.98 J/cm² | 1,2 J / cm² | Not available | 3.03J / cm² | Similar
Note4 |
| Visible Light
source | 120 Red LEDs | Not available | 105 Red LEDs | 119 Red LEDs | 180 pcs | Similar
Note5 |
| Distribution | Uniform
distribution | Not available | Not available | Uniform
distribution | Not available | Same |
| Treatment
protocol | every other day,
for 16 weeks | every other day,
for 16 weeks | 16 weeks | Not available | Total Treatment:
every two days | Similar
Note6 |
| Software
controller | Device uses a
timer and
software to
control treatment
duration | Device uses a
timer and
software to
control treatment
duration | Not available | Not available | Not available | Same |
| Power supply | Rechargeable
Lithium battery | Not available | Rechargeable
battery | Lithium Polymer | Not available | Same |
9
10
Comparison in Details:
Note1:
The subject device's wavelengths are the same as predicate device 4(K213025), and within the bandwidth of predicate device 1 (K211038) and predicate device 3 (K173729). So, the difference between the subject devices will not raise any safety or effectiveness issues.
Note2:
The total intensity of subject device is larger than predicate device 2(K193008) and predicate device 4(K213025). However, the subject device has the same / similar treatment parameters in "wavelength", "distribution" and
11
" treatment time" as the predicate device 3(K173729). So, the difference between the predicate devices will not raise any safety or effectiveness issues.
Note3:
The treatment time of subject time is the same as predicate device 3(K173729) and slightly different from other predicate devices, however, this slight difference won't raise any safety or effectiveness issues.
Note4:
The dose of subject device is larger than predicate device 4(K213025), and smaller than predicate device 1(K211038). the dose of subject device is within the range of dose of the 4 predicate device. The difference between the subject device and the predicate devices will not raise any safety or effectiveness issues.
Note5:
Although the amount of diodes of subject is slightly different from the predicate devices, the amount is larger than predicate device 2(K193008), predicate device 3 (K173729) and smaller than predicate device 4(K213025), it still falls within the range of these 4 predicate devices (the number of diodes is not too high or too low compared to the slightly difference between the subject device and the predicate devices will not raise any safety or effectiveness issues.
Note6:
The treatment protocol of subject device 1(K211038) and predicate device 2(K19300), Although it has a slightly difference with predicate device 4(K213025), this will not raise any safety or effectiveness issues,
Final Conclusion:
The subject device is the same or similar to the legally marketed predicate device K211038, K173729 and K213025.
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8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
8.1.1Safety and Performance Test
The HIGHERDOSE Red Light Hat has been evaluated the safety and performance by lab bench testing as following:
1). IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV (include IEC 60601-1-6:2010+A1:2013+A2:2020 ) Medical electrical equipment - Part 1). General requirements for basic safety and essential performance
2). IEC 60601-1-2:2014/AMD1:2020 Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
3). IEC 60601-1-11:2015/AMD1:2020 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
4). IEC 60601-2-57:2023 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
5). IEC 62471:2006 Photobiological safety of lamps and lamp systems.
All the test has been passed.
8.1.2Usability Test
Usability testing was conducted on the HIGHERDOSE Red Light Hat (Model: HG-120K), the device complies with IEC 62366-1 and IEC 60601-1-6.
8.1.3Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance "Content of Premarket Submissions for Device Software Functions -Guidance for Industry and Food and Drug Administration Staff."
8.1.4Cybersecurity
The subject device no any external interfaces, no need cybersecurity evaluation.
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8.2Biocompatibility testing
The component materials of the subject device are identical to the corresponding component materials of the previously cleared devices (K223893) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, 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 10993-23 (Irritation).
8.3 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 K211038, K193008, K173729 and K213025.