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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the HIGHERDOSE Red Light Hat (HG-120K), seeking substantial equivalence to predicate devices for treating Androgenetic Alopecia and promoting hair growth.

However, the documentation does not contain information regarding a clinical study with acceptance criteria and reported device performance related to hair growth outcomes. Instead, it focuses on non-clinical performance testing (electrical safety, EMC, usability, software verification, and biocompatibility) to demonstrate safety and effectiveness for a device marketed as an Over-The-Counter Infrared Lamp.

The document explicitly states: "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." This means that the FDA's clearance for this device was based on a comparison to predicate devices and engineering/safety tests, not on new clinical data demonstrating its efficacy in hair growth.

Therefore, it is not possible to extract the requested information from the provided text regarding:

A table of acceptance criteria and reported device performance for hair growth.
Sample size and data provenance for a test set proving hair growth efficacy.
Number and qualifications of experts for ground truth establishment for hair growth.
Adjudication method for a hair growth test set.
MRMC comparative effectiveness study for human readers with and without AI assistance for hair growth.
Standalone performance of an algorithm without human-in-the-loop for hair growth.
Type of ground truth used for a hair growth study.
Sample size for a training set (as no AI algorithm for diagnosis/prognosis is implied).
How ground truth for a training set was established.

The document primarily addresses the substantial equivalence requirements by comparing the technical specifications and intended use of the HIGHERDOSE Red Light Hat with previously cleared infrared lamp devices, and by demonstrating compliance with relevant electrical and safety standards.

Summary

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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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the 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).

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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

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Indications for Use

Submission Number (if known)

K242363

Device Name

HIGHERDOSE RED LIGHT HAT (HG-120K)

Indications for Use (Describe)

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

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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

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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.

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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.

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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 ofComparison	Subject Device	PredicateDevice1	Predicate Device2	Predicate Device3	Predicate Device4	Remark
	Company	Shenzhen KaiyanMedicalEquipment Co,.Ltd	Biophotas Inc	ADVIHAIR S.R.L.	PhotonMD, Inc	Kam Yuen PlasticProducts Ltd.
Trade Name	HIGHERDOSERed Light Hat	BiophotasCellumaRESTORE	Tricoglam HomeUse	Revian Red	Laser hair growthhelmet	–
ClassificationName	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 DeviceClassification	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 forUse	TheHIGHERDOSERed Light Hat isused to treatAndrogeneticAlopecia and	The BioPhotasCellumaRESTORE isindicated to treatAndrogeneticAlopecia andpromote hairgrowth in maleswho haveNorwood-	Tricoglam HomeUse is indicatedto promote hairgrowth in femaleswith and rogeneticalopecia who	The REVIAN REDdevice isindicated to treatAndrogeneticAlopecia and toPromote Hair	The Laser hairgrowth helmet(Model: A-800) isintended for thepromotion of hairgrowth in females	Same
	promote hair	Hamilton	have LudwigSavin	Growth in males	with androgenic
	growth in males	Classifications ofIla - 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	SimilarNote1
Total Intensity(mW/cm2)	5 mW/cm²	2.77 mW/cm²	525 mW	Not available	2.02 mW/cm²	SimilarNote2
Treatment Time	10 minutes	30 min	20 minutes incontinuous everyday	Every day 10mins	Each Treatment:25 min	SimilarNote3
Dose	Red: 3J/cm²	4.98 J/cm²	1,2 J / cm²	Not available	3.03J / cm²	SimilarNote4
Visible Lightsource	120 Red LEDs	Not available	105 Red LEDs	119 Red LEDs	180 pcs	SimilarNote5
Distribution	Uniformdistribution	Not available	Not available	Uniformdistribution	Not available	Same
Treatmentprotocol	every other day,for 16 weeks	every other day,for 16 weeks	16 weeks	Not available	Total Treatment:every two days	SimilarNote6
Softwarecontroller	Device uses atimer andsoftware tocontrol treatmentduration	Device uses atimer andsoftware tocontrol treatmentduration	Not available	Not available	Not available	Same
Power supply	RechargeableLithium battery	Not available	Rechargeablebattery	Lithium Polymer	Not available	Same

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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

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" 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.

Regulation Number and Section

§ 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.