CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)

K261675 · Shenzhen Chuanghong Zhilian Technology Co., Ltd. · OAP · Jul 17, 2026 · Physical Medicine

Device Facts

• Record ID: K261675
• Device Name: CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)
• Applicant: Shenzhen Chuanghong Zhilian Technology Co., Ltd.
• Product Code: OAP · Physical Medicine
• Decision Date: Jul 17, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

CHZL Red Light Therapy Hair Growth Cap (Model(s): CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV. The device is intended for use in adults (22 years of age and older).

Device Story

Low-level laser therapy (LLLT) device; wearable cap containing visible red laser diodes (LDs) and LEDs (650nm, 5mW each). Powered by rechargeable lithium battery; user-operated via controller for on/off, mode, and time settings (10 or 20-minute sessions). Intended for home use by adults to treat androgenic alopecia. Device exposes scalp to light to promote hair growth. Safety features include automatic shut-off.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes biocompatibility (ISO 10993-5, -10, -23), electrical safety (IEC 60601-1, -1-2, -1-11, -2-83), battery safety (IEC 62133-2), laser safety (IEC 60825-1), and photobiological safety (IEC 62471).

Technological Characteristics

LLLT cap; 650nm wavelength; 5mW per diode. Models vary by diode configuration (120 LEDs, 120 LDs, or 60 LEDs/60 LDs). Rechargeable lithium battery power. Biocompatible materials per ISO 10993. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83, IEC 60825-1, IEC 62471, IEC 62133-2.

Indications for Use

Indicated for adults (22+) with Androgenic Alopecia to promote hair growth. Males: Norwood-Hamilton IIa-V. Females: Ludwig (Savin) I-1 to I-4, II-1, II-2, or frontal. Skin types: Fitzpatrick I-IV.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap (K240456)
• HIGHERDOSE Red Light Hat (HG-120K) (K242363)
• Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) (K250308)

Submission Summary (Full Text)

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**FDA** U.S. FOOD & DRUG
ADMINISTRATION

July 17, 2026

Shenzhen Chuanghong Zhilian Technology Co., Ltd.

% Bing Huang

Registration specialist

Feiying Drug & Medical Consulting Technical Service Group

Rm.2401 Zhenye International Business Center, # 3101-90, Qianhai Rd.

Shenzhen, Guangdong 518052

China

Re: K261675

Trade/Device Name: CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)

Regulation Number: 21 CFR 890.5500

Regulation Name: Infrared Lamp

Regulatory Class: Class II

Product Code: OAP

Dated: May 21, 2026

Received: May 21, 2026

Dear Bing Huang:

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 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

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K261675 - Bing Huang

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

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K261675 - Bing Huang

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(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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

TANISHA L. HITHE -S Digitally signed by TANISHA L. HITHE -S Date: 2026.07.17 16:56:48 -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

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261675 |
| Please provide the device trade name(s). | | ? |
| CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | | |
| Please provide your Indications for Use below. | | ? |
| CHZL Red Light Therapy Hair Growth Cap (Model(s): CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.The device is intended for use in adults (22 years of age and older). | | |
| Please select the types of uses (select one or both, as applicable). | □ Prescription Use (21 CFR 801 Subpart D)× Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | □ Neonates/Newborns (Birth to < 29 days old)□ Infants (29 days old to < 2 years old)□ Children (2 years old to < 12 years old)□ Adolescents (12 years old to < 22 years old)× Adults (22 years old and greater) | ? |

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Shenzhen Chuanghong Zhilian Technology Co., Ltd
510(k)s –510(k) Summary

# 510(k) Summary

"510(k) Summary" as required by 21 CFR Part 807.92.

K261675

Date: 2026-07-09

## I. Submitter’s Information

Sponsor Name: Shenzhen Chuanghong Zhilian Technology Co., Ltd
Address: 3rd Floor, Building 4, No. 26 Dawangshan Industrial Road, Dawangshan Community,
Shajing Street, Bao'an District, Shenzhen.
Post code: 518000
Tel.: [phone]
Contact person: Ya Huang
Title: Department Supervisor
Tel.: [phone]
Email: [e-mail]

### Distributor

Company Name: Shenzhen Chuanghong Zhilian Technology Co., Ltd
Address: 3rd Floor, Building 4, No. 26 Dawangshan Industrial Road, Dawangshan Community,
Shajing Street, Bao'an District, Shenzhen.
Post code: 518000
Tel.: [phone]
Contact person: Ya Huang
Email: [e-mail]

### Manufacture

Manufacture Name: GYMMAX TECHNOLOGY SHENZHEN CO.,LTD.
Address: 4F & 5F, 4th Bldg, Heping Complex (4th Bldg. Huimingsheng Technology Park) Fuhai
Subdistrict, Baoan District Shenzhen City, Guangdong, CN
Post code: 518103
Tel.:[phone]

## II. Device

Name of Device: CHZL Red Light Therapy Hair Growth Cap
Model(s): CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D
Common or Usual Name: Laser, Comb, Hair
Classification Name: Laser surgical instrument for use in general and plastic surgery and in
dermatology
Regulatory Class: II

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Shenzhen Chuanghong Zhilian Technology Co., Ltd
510(k)s -510(k) Summary---

Product Code: OAP
Regulation Number: 21CRF 890.5500
Review Panel: General & Plastic Surgery

### III. Predicate Device

| Manufacturer | Predicate Device | 510(k) Number | Clearance Date |
| --- | --- | --- | --- |
| Beijing Top Laser Technology Co., Ltd. | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | K240456 | May 22,2024 |
| SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD | HIGHERDOSE Red Light Hat (HG-120K) | K242363 | November 20,2024 |
| Dongguan Boyuan Intelligent Technology Co., Ltd. | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) | K250308 | April 29, 2025 |

### IV. Device Description

CHZL Red Light Therapy Hair Growth Cap (Model(s): CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) is low-level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the light therapy of visible, red laser diodes (LDs) and LEDs at 650nm and 5mW each. The LDs and LEDs are contained inside a lightweight cap. The device is powered by a built-in rechargeable lithium battery and automatically turns of after 10 or 20 minutes. The device has a controller for operating the on /off , mode switch and time switch.

### V. Indications for Use

CHZL Red Light Therapy Hair Growth Cap (Model(s): CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV. The device is intended for use in adults (22 years of age and older).

### VI. Comparison of Technological Characteristics With the Predicate Device

CHZL Red Light Therapy Hair Growth Cap is compared with the following Predicate Devices in terms of intended use, design, specifications, and performance:

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Shenzhen Chuanghong Zhilian Technology Co., Ltd
510(k)s -510(k) Summary

| Comparison Elements | Subject Device | Primary Predicate Device | Predicate Device 2 | Predicate Device 3 | Remark |
| --- | --- | --- | --- | --- | --- |
| 510(k) Number | K261675 | K240456 | K242363 | K250308 | / |
| Trade name | CHZL Red Light Therapy Hair Growth Cap (Models: CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | HIGHERDOSE Red Light Hat (HG-120K) | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) | / |
| Manufacturer | GYMMAX TECHNOLOGY SHENZHEN CO.,LTD. | Beijing Top Laser Technology Co., Ltd. | SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD | Dongguan Boyuan Intelligent Technology Co., Ltd. | / |
| Regulation number | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | Same |
| Product code | OAP | OAP | OAP | OAP | Same |
| Device classification | Class II | Class II | Class II | Class II | Same |
| Prescription or OTC | OTC | OTC | OTC | OTC | Same |
| Indication for use/ Intended use | CHZL Red Light Therapy Hair Growth Cap is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat | Indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V and females with androgenetic alopecia who | 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 | Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who | Same |

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Shenzhen Chuanghong Zhilian Technology Co., Ltd
510(k)s -510(k) Summary

| Comparison Elements | Subject Device | Primary Predicate Device | Predicate Device 2 | Predicate Device 3 | Remark |
| --- | --- | --- | --- | --- | --- |
| | Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV. The device is intended for use in adults (22 years of age and older). | have Ludwig-Savin Classifications of I - II and Fitzpatrick Classification of Skin Phototypes I to IV. | to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have LudwigSavin Scale 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV. | have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV. | |
| Intended User | Female and Males | Female and Males | Female and Males | Female and Males | Same |
| Intended location of use | Scalp | Scalp | Scalp | Scalp | Same |
| Helmet/Cap design | Cap | Cap | Cap | Helmet | Same |
| Mode of Operation | Low-level laser diodes and light-emitting diodes | Low-level laser diodes and light-emitting diodes | Light emitting diodes | Visible red laser | Same |
| Wavelength | 650nm ± 10nm | 650 nm | Red: 650nm ± 10nm | 650 ± 20nm | Same |
| Amount of diodes | CHZL-120BK-L52D: 120LEDs CHZL-120BK-L53D: 120LDs CHZL-120BK-L54D: 60LEDs+60LDs | 128 model: 57LDs+77LEDs 162 model: 65LDs+97LEDs 288 mode:115LDs+173LEDs | 120 Red LEDs | 56, 88, 120,200 | Same |

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Shenzhen Chuanghong Zhilian Technology Co., Ltd

510(k)s -510(k) Summary

| Comparison Elements | Subject Device | Primary Predicate Device | Predicate Device 2 | Predicate Device 3 | Remark |
| --- | --- | --- | --- | --- | --- |
| Power Output | \( \leqslant 5mW \) | 5mW per light | Unknown | 5mW | Same |
| Classification according to IEC 60825-1 | Class 3R | Class 3R | / | Class 3R | Same |
| Treatment duration | 10, 20minutes10miunet every day, for 16weeks20minutes every other day for 16 weeks | 25 minutes every day | 10 minutesEvery other day, for 16weeks | Each Treatment: 30 minutes.Total Treatment: once every 2 days, for 16 weeks | Same |
| Power supply | Rechargeable Lithium battery | Power supply | Rechargeable Lithium battery | Rechargeable Lithium battery | Same |
| Total Irradiance | CHZL-120BK-L52D:\( 1.8 \sim 4.2mW/cm^{2} \)CHZL-120BK-L53D:\( 0.8 \sim 2.9mW/cm^{2} \)CHZL-120BK-L54D:\( 1.3 \sim 3.4mW/cm^{2} \) | 128 model: \( 1.43mW/cm^{2} \)162 model: \( 1.68mW/cm^{2} \)288 model: \( 2.47mW/cm^{2} \) | \( 5mW/cm^{2} \) | \( 2.56mW/cm^{2} \) | Similar Note 1 |
| Distribution | Uniform | Uniform | Uniform | Unknown | Same |
| Electrical safety | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83IEC 62471IEC 60825-1 | IEC 60601-1,IEC 60601-11,IEC 60601-2-22,IEC 60825-1 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 60247 | IEC 60601-1IEC 60601-1-2IEC 60825-1IEC 60601-1-11IEC 60601-2-57 | Same |
| Biocompatibility feature | All patient contacting materials are complied with ISO 10993-5,ISO 10993-10 and ISO 10993-23 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10 | Same |

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Shenzhen Chuanghong Zhilian Technology Co., Ltd
510(k)s –510(k) Summary

# VII. Performance Data

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

# 1) Biocompatibility Safety

The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020" , as recommended by FDA. The following testing was performed to, and passed, including:

> ISO 10993-5: 2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
> ISO 10993-10: 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
> ISO 10993-23: 2021, Biological evaluation of medical devices - Part 23: Tests for irritation

# 2) Electrical Safety and EMC Safety

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

> IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
\(\succ\) IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
\(\succ\) IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, Medical Electrical Equipment -Part 1: 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
\(\succ\) IEC 60601-2-83: 2022 Medical Electrical Equipment - Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment
\(\succ\) IEC 62133-2 Edition 5.0 2021-09 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
\(\succ\) IEC 60825-1: 2014 Safety of laser products - Part 1: Equipment classification and requirements.

# 3) Eye Safety

➤ IEC 62471:2006 Photobiological safety of lamps and lamp systems

# 4) Software Verification and Validation

Software documentation consistent with Basic Documentation of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

# Summary

Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate device.

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Shenzhen Chuanghong Zhilian Technology Co., Ltd
510(k)s –510(k) Summary---

### VIII. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the subject device CHZL Red Light Therapy Hair Growth Cap is to be concluded substantial equivalent to its predicate devices.

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