K Number
K213020
Device Name
IPL hair removal machine
Date Cleared
2021-12-16

(87 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Device Description
The BR2020 IPL hair removal machine is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the treatment window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse.
More Information

No
The description focuses on standard IPL technology and safety features, with no mention of AI or ML capabilities. The "Not Found" entries for AI/ML mentions and training/test sets further support this conclusion.

No.
The device is described as an IPL hair removal machine, and its intended use is for "removal of unwanted hair" and "hair reduction" for cosmetic purposes, not for treating a disease or medical condition.

No

This device is intended for hair removal, which is a cosmetic procedure, not a diagnostic one. It does not identify, assess, or monitor a disease or condition.

No

The device description explicitly states it consists of an "IPL main body and power adapter two parts" and uses a "Xenon flashlamp" for optical radiation, indicating it is a hardware device with embedded software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the removal of unwanted hair on the body. This is a cosmetic or aesthetic procedure performed directly on the patient's body.
  • Device Description: The device uses Intense Pulsed Light (IPL) technology to target hair follicles. This is a physical interaction with the body, not a test performed on a sample taken from the body.
  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform any such testing on biological samples.

The device is clearly described as a personal, light-based hair reduction device for over-the-counter sale and use directly on the skin. This aligns with the definition of a non-IVD medical device used for aesthetic purposes.

N/A

Intended Use / Indications for Use

IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

Product codes

OHT

Device Description

The BR2020 IPL hair removal machine is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the treatment window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Intense Pulsed Light (IPL)

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

personal, over-the-counter

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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

  1. Biocompatibility Testing
    The biocompatibility evaluation for the body-contacting components of the subject device was conducted 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", as recognized by FDA. The battery of testing was performed to, and passed, including:
  • A ISO 10993-5 Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
  • ISO 10993-10 Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization

  1. Electrical Safety and Eye Safety
    Electrical safety and Eye safety testing was performed to, and passed, the following standards:
  • A IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
  • IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance

  • A IEC 60601-1-11 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
  • IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the A basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
  1. Eye Safety
  • A IEC 62471 Photobiological safety of lamps and lamp systems
  1. Software Verification and Validation
    Software documentation consistent with moderate level 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 IPL hair removal machine was found to have a safety and effectiveness profile that is similar to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K210311

Reference Device(s)

K203510, K160968

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

December 16, 2021

Shenzhen Borria Technology Co.,Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhen Ye International Center, No. 3101-90 Qianhai Road, Nanshan District Shenzhen, Guangdong 518000 China

Re: K213020

Trade/Device Name: IPL hair removal machine Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT Dated: September 10, 2021 Received: September 20, 2021

Dear Rain Yip:

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 (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 located 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.

1

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213020

Device Name

IPL hair removal machine, model: BR2020

Indications for Use (Describe)

IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

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

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

Date: 2021-09-10

I. Submitter

SHENZHEN BORRIA TECHNOLOGY CO.,LTD

22A, Tianmian City Building, No.4026 Shennan Middle Road, Tianmian Community, Huafu Street, Futian District, Shenzhen, China Post code: 518100 Tel.: +86 755 8317 6765

Li Zhenqiang Project Manager Tel: +86 755 8317 6765 Email: lzq_21@126.com

II. Device

Name of Device: IPL hair removal machine Model: BR2020 Common or Usual Name: Light Based Over-The-Counter Hair Removal Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810

III. Predicate Device

Primary predicate device: Manufacturer Predicate Device Shenzhen Mismon Home Use IPL Beauty Technology Co.. Ltd Device/MS-208B

Reference devices:
ManufacturerPredicate Device510(k) NumberApproval Date
Shenzhen Weikai
Technology CO.,LTDIPL Hair removalK203510Feb. 26, 2021
CYDEN LIMITEDiPulse Smooth Gold Hair
Removal SystemK160968Apr. 14, 2016

510(k) Number

K210311

IV. Device Description

Approval Date

Jul. 23, 2021

4

The BR2020 IPL hair removal machine is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the treatment window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse.

V. Indications for Use

IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

VI. Comparison of Technological Characteristics With the Predicate Device

The IPL hair removal machine has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the IPL hair removal machine may be found substantially equivalent to its predicate device. IPL hair removal machine is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance:

Comparison ElementsSubject DevicePredicate Device K210311
K NumberPendingK210311
Trade nameIPL hair removal machineHome Use IPL Beauty Device
Model: MS-208B
Wavelength range510-1200nm510-1100nm
Energy mediumXenon Arc FlashlampXenon Arc Flashlamp
Energy density2.7~5.0 J/cm²2.0~5.1J/cm²
Spot size3.0cm²3.6cm2
Pulse duration7.9-11.4ms9-12ms
Pulsing controlFinger switchFinger switch
Delivery deviceDirect illumination tissueDirect illumination tissue
Indication
for
use/Intended useIPL hair removal machine is an
over-the-counter device intended
for removal of unwanted hair such
as but not limited to small areas
such as underarm and facial hair
below the chin line and large
areas such as legs.The Home Use IPL Beauty
Device is an over-the-counter
device intended for removal of
unwanted hair such as but not
limited to small areas such as
underarm and facial hair below
the chin line and large areas such
as legs.

5

Comparison ElementsSubject DevicePredicate Device K210311
Location for useOTCOTC

VII.Performance Data

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

1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the subject device was conducted 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", as recognized by FDA. The battery of testing was performed to, and passed, including:

  • A ISO 10993-5 Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
  • ISO 10993-10 Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization

2) Electrical Safety and Eye Safety

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

  • A IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
  • IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance

  • A IEC 60601-1-11 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
  • IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the A basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

3) Eye Safety

  • A IEC 62471 Photobiological safety of lamps and lamp systems

4) Software Verification and Validation

Software documentation consistent with moderate level 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

6

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

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 IPL hair removal machine is to be concluded substantial equivalent to its predicate devices.