Breo Laser Hair Growth Comb is indicated to treat Androgenetic Aloperia, and promote hair growth in females who have Ludwig (Savin) 1-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.

Device Description

Breo Laser Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The device also has a massage function which is a mechanical vibration function.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Breo Laser Hair Growth Comb (Scalp 3L)". It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for a novel AI/medical device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI algorithm performance or direct clinical efficacy studies with specific metrics) are not present in the provided text. The document states "Clinical study: Not applicable" (Section 9), indicating that a clinical trial to prove efficacy or safety in the traditional sense was not required for this 510(k) clearance due to the device's similarity to an already cleared predicate.

Here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device (Laser Therapy Hair Growth Comb, Lasercomb-001, K230134). This means the device performs similarly in terms of its technical specifications and intended use.

Acceptance Criterion (Implicitly Met by Equivalence)	Reported Device Performance (Subject Device: Breo Laser Hair Growth Comb Scalp 3L)	Predicate Device Performance (Lasercomb-001)
Intended Use/Indications for Use: Treatment of Androgenetic Alopecia, promotion of hair growth in specific Ludwig (Savin) classifications for females and Norwood Hamilton classifications for males, both with Fitzpatrick Skin Types I to IV.	Same	Same
Location for Use: OTC application	OTC application	OTC application
Type of Laser: Visible red light-emitting diodes	Visible red light-emitting diodes	Visible red light-emitting diodes
Wavelength: 650nm ± 10nm	650nm ± 10nm	650nm ± 10nm
Amount of Laser Diodes: 7	7	7
Energy per Laser Diode: < 5mW	4.89 mW (< 5mW)	4.63 mW, 4.56 mW, 4.66 mW, 4.78 mW, 4.86 mW, 4.78 mW (implicitly < 5mW)
Laser Classification (IEC 60825-1): Class 3R	Class 3R	Class 3R
Treatment Time: 15 min per treatment	15 min per treatment	15 min per treatment
Treatment Frequency: 3 times per week, spaced every other day, as little as 16 weeks	3 times per week, spaced every other day, as little as 16 weeks	3 times per week, spaced every other day, as little as 16 weeks
Applicable People (Hair Loss Classification): Norwood-Hamilton IIa~~V (males), Ludwig-Savin I~~II (females)	Norwood-Hamilton IIa~~V (males), Ludwig-Savin I~~II (females)	Norwood-Hamilton IIa~~V (males), Ludwig-Savin I~~II (females)
Applicable Skin: Fitzpatrick Skin Phototypes I-IV	Fitzpatrick Skin Phototypes I-IV	Fitzpatrick Skin Phototypes I-IV
Shape Design: Comb	Comb	Comb
Safety Features (Compliance): IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60825-1, IEC 62133 (Battery)	Complied with listed standards	Complied with listed standards
Biocompatibility: All body contacting materials compliant with ISO 10993-5, -10, -23	Complied with listed standards	Complied with listed standards
Electrical Safety & EMC: Compliance with specified standards	Passed specified standards	Passed specified standards

Study Details (Based on the Provided Document)

As noted, the document explicitly states "Clinical study: Not applicable." The demonstration of the device meeting acceptance criteria is primarily through the comparison of technical specifications and safety standards compliance to a legally marketed predicate device. Therefore, many standard questions about AI/medical device study design are not applicable here.

Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is described for efficacy. Safety testing (biocompatibility, electrical safety, EMC) is done on the device itself, not on a human population test set for efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic or therapeutic device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for effectiveness/clinical performance. For safety and functional performance, the "ground truth" is compliance with established international standards (IEC, ISO) and the comparable performance of the predicate device.
The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/machine learning device requiring such.
How the ground truth for the training set was established: Not applicable.

Summary

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November 1, 2024

Shenzhen Breo Technology Co., Ltd. % Jie Yang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K242620

Trade/Device Name: Breo Laser Hair Growth Comb (Scalp 3L) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP, ISA Dated: September 3, 2024 Received: September 3, 2024

Dear Jie Yang:

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 (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 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.

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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 QS 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 bear a unique 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). 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-regulatory

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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,

Yan Fu -S

Digitally signed by Yan
Fu -S
Date: 2024.11.01
13:03:09 -04'00'

for

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

510(k) Number (if known) K242620

Device Name Breo Laser Hair Growth Comb (Scalp 3L)

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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510(K) Summary - K242620

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2024/10/28

Submission sponsor 1.

Name: Shenzhen Breo Technology Co., Ltd.

Address: 19/F Hisense Southen Building No.1777, Chuangye Road, Nanshan District,

Shenzhen, Guangdong, 518054, China

Contact person: Zhou Yong

Title: Regulatory engineer

E-mail: Zhouy@breo.com

Tel: 0755-82073336

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Yang Jie E-mail: yangjie(@chonconn.com Tel: +86-755 33941160

Trade/Device Name	Breo Laser Hair Growth Comb
Model	Scalp 3L
Common Name	Laser therapy hair growth comb
Regulatory Class	Class II
Classification	21CFR890.5500 / Infrared lamp / OAP21CFR 890.5660/ Therapeutic massager/ ISA
Submission type	Traditional 510(K)

Subject Device Information 3.

4. Predicate Device

510(k) number: K230134 Product name: Laser Therapy Hair Growth Comb, Lasercomb-001 Product code: OAP, ISA

Device Description 5.

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The device also has a massage function which is a mechanical vibration function.

Intended use & Indication for use 6.

Breo Laser Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.

7. Comparison to the Predicate Device
Features	Subject Device	Predicate Device	Comparison
	Breo Laser Hair GrowthComb Scalp 3L	Laser Therapy HairGrowth CombLasercomb-001
K Number	K242620	K230134	/
Classificationname	Infrared Lamp	Infrared Lamp	Same
Product code	OAP,ISA	OAP,ISA	Same
Intendeduse/Indicationsfor Use	Breo Laser Hair GrowthComb is indicated totreat AndrogeneticAlopecia, and promotehair growth in femaleswho have Ludwig(Savin) I-4, II-1, II-2, orfrontal patterns of hairloss and in males whohave Norwood HamiltonClassifications of IIa toV and who both haveFitzpatrick Skin Types Ito IV.	Laser Therapy HairGrowth Comb isindicated to treatAndrogenetic Alopecia,and promote hair growthin females who haveLudwig (Savin) I-4, II-1,II-2, or frontal patternsof hair loss and in maleswho have NorwoodHamilton Classificationsof IIa to V and who bothhave Fitzpatrick SkinTypes I to IV.	Same
Location for use	OTC application	OTC application	Same
Type of laser	Visible red light-emittingdiodes	Visible red light-emittingdiodes	Same
Wavelength	650nm±10nm	650nm±10nm	Same
Amount of laserdiodes	7	7	Same
Energy of perlaser diode	4.89 mW < 5mW	4.63 mW, 4.56 mW,4.66 mW, 4.78 mW,4.86 mW, 4.78 mW	Same
Features	Subject Device	Predicate Device	Comparison
	Breo Laser Hair GrowthComb Scalp 3L	Laser Therapy HairGrowth CombLasercomb-001$4.89 mW < 5mW$
Classificationaccording toIEC60825-1	Class 3R	Class 3R	Same
Treatment time	15 min per treatment	15 min per treatment	Same
Treatmentfrequency	3 times per week, spacedout every other day, aslittle as 16 weeks	3 times per week,spaced out every otherday, as little as 16 weeks	Same
Applicablepeople	Norwood-HamiltonIIa~~V (males) Ludwig-Savin I~~II (females)	Norwood-HamiltonIIa~~V (males) Ludwig-Savin I~~II (females)	Same
Applicable skin	Fitzpatrick SkinPhototypes I-IV	Fitzpatrick SkinPhototypes I-IV	Same
Shape design	Comb	Comb	Same
Safety feature	Complied withIEC60601-1, IEC60601-1-11, IEC60601-1-2 andIEC60825-1Complied with IEC62133 (Battery pack)	Complied withIEC60601-1, IEC60601-1-11, IEC60601-1-2 andIEC60825-1Complied with IEC62133 (Battery pack)	Same
Biocompatibility	All body contactingmaterials are compliedwith ISO10993-5 andISO 10993-10, ISO10993-23	All body contactingmaterials are compliedwith ISO10993-5 andISO 10993-10, ISO10993-23	Same

Comparison to the Predicate Device ד

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Non-clinical tests 8.

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Biocompatibility of the subject device was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

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Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC safety testing was performed to, and passed, the following standards:

· ANSI AAMI ES60601-1:2005/A1:2012+A2:2020 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015+A1:2020 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
IEC 60601-1-2:2014+A1:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility Requirements and tests

In addition, testing to IEC 60825-1:2014 certifies the laser system to classification 3R, which is the same as the predicate devices.

The battery conforms to IEC 62133-2:2017/AMD1:2021.

Clinical study 9.

Not applicable.

10. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the subject device is substantially equivalent to the predicate device.

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.