(59 days)
No
The summary describes a low-level laser therapy device with a massage function and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated to treat Androgenetic Alopecia and promote hair growth, which are therapeutic claims.
No
The device is described as a "low level laser therapy device that emits laser light designed to promote hair growth" and has a "massage function". Its intended use is to "treat Androgenetic Aloperia, and promote hair growth". These functions are therapeutic, not diagnostic.
No
The device description explicitly states it is a "hand-held comb-shaped low level laser therapy device" with a "mechanical vibration function," indicating it is a physical hardware device that emits laser light and provides massage.
Based on the provided information, the Breo Laser Hair Growth Comb is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Breo Laser Hair Growth Comb is a physical device that applies low-level laser therapy directly to the scalp. It does not analyze any biological samples.
- Intended Use: Its intended use is to treat a condition (Androgenetic Alopecia) and promote hair growth through direct application of light and massage, not through the analysis of in vitro specimens.
Therefore, the Breo Laser Hair Growth Comb falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OAP, ISA
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.
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
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
Not applicable.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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.
| 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 / OAP |
| 21CFR 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.
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.
5
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 Growth | |||
| Comb Scalp 3L | Laser Therapy Hair | ||
| Growth Comb | |||
| Lasercomb-001 | |||
| K Number | K242620 | K230134 | / |
| Classification | |||
| name | Infrared Lamp | Infrared Lamp | Same |
| Product code | OAP,ISA | OAP,ISA | Same |
| Intended | |||
| use/Indications | |||
| for Use | 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. | Laser Therapy 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. | Same | ||
| Location for use | OTC application | OTC application | Same |
| Type of laser | Visible red light-emitting | ||
| diodes | Visible red light-emitting | ||
| diodes | Same | ||
| Wavelength | 650nm±10nm | 650nm±10nm | Same |
| Amount of laser | |||
| diodes | 7 | 7 | Same |
| Energy of per | |||
| laser diode | 4.89 mW |