Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard IPL technology, electrical safety, and software validation for basic device function (like the skin sensor). There is no mention of AI/ML terms, data sets, or performance metrics typically associated with AI/ML algorithms.

Therapeutic

No
The device is described as an over-the-counter hair removal device. It is intended for cosmetic purposes (removal of unwanted hair), not for diagnosing, treating, or preventing disease or affecting the structure or function of the body for medical purposes, which are characteristics of a therapeutic device.

Diagnostic

No

The intended use of the device is for hair removal, not for diagnosing any medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a Xenon lamp, skin sensor, external power adapter, and a finger switch for IPL emission. It also mentions physical differences between models like appearance and lamp cartridge quantity. While software verification and validation are mentioned, the core functionality relies on physical hardware.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

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 about a person's health.
Device Function: The IPL Home Use Hair Removal Device uses light energy applied externally to the skin to reduce hair growth. It does not analyze any biological samples.
Intended Use: The intended use is for "removal of unwanted body and/or facial hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.

The information provided clearly describes a device that interacts with the body's surface using light, not a device that analyzes biological samples for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Product codes (comma separated list FDA assigned to the subject device)

OHT

Device Description

The IPL Home Use Hair Removal Device 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. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.

The IPL Home Use Hair Removal Device includes D-1103, D-1119, D-1129 and D-1130 five models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, LCD display contents, hair removal lamp cartridge's quantity and appearance, as well as lamp tube's placement location; in addition, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) is different; but these differences do not affect or change the intended use of the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body and/or facial

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-the-counter device intended for removal of unwanted body and/or facial hair.

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.

Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Home Use Hair Removal 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, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:

ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization

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

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
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

Eye Safety

IEC 62471 Photobiological safety of lamps and lamp systems

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, IPL Home Use Hair Removal Device 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161428, K181568, K160968

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

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

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 8, 2019

Shenzhen Bosidin Technology Co. Ltd. % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005. Area B. Bldg. 1. Southward Ruifeng Business Center Guimiao Road Shenzhen, 518000 CN

Re: K192432

Trade/Device Name: IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 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: August 21, 2019 Received: September 5, 2019

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

1

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

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 medical devices and radiation-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 Pandva Acting 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) K192432

Device Name IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130

Indications for Use (Describe)

IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

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: 2019-08-21

I. Submitter

Shenzhen Bosidin Technology Co.,Ltd. Rm.101&201, Bldg.4, Haoer Jiashitai Technology Park, Fengtang Avenue No.164, Heping Community, Fuhai Street, Bao'an District, Shenzhen, Guangdong, China Post code: 518100 Tel.: +86 755 3388 3239

WANG JIAOYAN General Manager Assistant Tel: +86 137 9835 8583 Email: 970207667@qq.com

II. Device

Name of Device: IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 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

Manufacturer	Predicate Device	510(k) Number	Approval Date
Shen Zhen CosBeauty Co.,
Ltd	PerfectSmooth/CB-014	K161428	Mar. 23, 2017
Medical Device Branch of
Zhangzhou Easepal
Industiral Co.,Ltd.	IPL Salon Hair Reduction
System/F60001	K181568	Sep. 11, 2018
CyDen Limited.	iPulse SmoothSkin Gold
Hair Removal System	K160968	Apr.04, 2016

IV. Device Description

The IPL Home Use Hair Removal Device 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

4

using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.

The IPL Home Use Hair Removal Device includes D-1103, D-1119, D-1129 and D-1130 five models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, LCD display contents, hair removal lamp cartridge's quantity and appearance, as well as lamp tube's placement location; in addition, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) is different; but these differences do not affect or change the intended use of the device.

V. Indications for Use

IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

VI. Comparison of Technological Characteristics With the Predicate Device

The IPL Home Use Hair Removal Device 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 Home Use Hair Removal Device may be found substantially equivalent to its predicate device.

IPL Home Use Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:

K181568, "IPL Salon Hair Reduction System", manufactured by "Medical Device Branch of Zhangzhou Easepal Industiral Co.,Ltd." in Fujian, China
K161428, "PerfectSmooth", manufactured by "Shen CosBeauty Co., Ltd" in Guangdong, China
K160968, "iPulse SmoothSkin Gold Hair Removal System ", manufactured by "CyDen Limited" in Wales, UK

| Comparison

Elements	Subject Device	Predicate Device
		K161428
(Primary)	K181568	K160968
K Number	Pending	K161428	K181568	K160968
Trade name	IPL Home Use
Hair Removal
Device	PerfectSmooth	IPL Salon Hair
Reduction
System	iPulse
SmoothSkin
Gold Hair
Removal System
Wavelength	Regular window:	$≥$ 510nm	475-1200nm	510-1100nm
Comparison
Elements	Subject Device	Predicate Device
		K161428
(Primary)	K181568	K160968
range	510-1100nm
Filter window: 600-
1100nm
Energy
medium	Xenon Arc
Flashlamp	Xenon Arc
Flashlamp	Xenon Arc
Flashlamp	Xenon Arc
Flashlamp
Energy density	2.0~4.0J/cm2
(applicable for
model D-1128, D-
1119, D-1129, D-

5

6

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 IPL Home Use Hair Removal 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, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:

ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010/(R)2014, 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:

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
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

7

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

3) Eye Safety

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

Based on the above performance as documented in this application, IPL Home Use Hair Removal Device 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 IPL Home Use Hair Removal Device is to be concluded substantial equivalent to its predicate devices.