K Number

Device Name

IPL Hair Removal Device (BE965A, BE965B, BE965C)

Manufacturer

Shenzhen Yang Wo Electronic Co., Ltd.

Date Cleared

2025-03-19

(57 days)

Product Code

OHT

Regulation Number

878.4810

Intended Use

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

Device Description

IPL Hair Removal Device is an over-the-counter, light based device for unwanted hair removal by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any culling, removing hair growth with minimal pain. The device includes three models with the only difference in enclosure color. It is only power adapter and its PL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a sapplire cooling function for a better hair removal experience.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K241998, K241834

Reference Devices

K241205

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard IPL technology, safety features like a skin sensor, and compliance with electrical and safety standards. There is no mention of AI, ML, image processing, or data training/testing sets, which are typical indicators of AI/ML integration in medical devices.

Therapeutic

No
The device is intended for the removal of unwanted hair, which is a cosmetic purpose, not a therapeutic one for a medical condition.

Diagnostic

No
The device is described as an "IPL Hair Removal Device" intended for "removal of unwanted body and/ or facial hair," indicating a therapeutic/cosmetic purpose rather than diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly details hardware components such as a power adapter, switch, skin sensor, and sapphire cooling function, indicating it is a physical device utilizing IPL technology, not software only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is "removal of unwanted body and/ or facial hair." This is a cosmetic or aesthetic purpose, not a diagnostic one.
Device Description: The description focuses on the mechanism of action (IPL technology for hair removal) and safety features (skin sensor, cooling function). It does not mention any analysis of biological samples or diagnostic procedures.
Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Using reagents or assays.

The device is clearly intended for a physical treatment (hair removal) and is classified as an over-the-counter device for that purpose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

OHT

Device Description

The device includes three models with the only difference in enclosure color. It is only power adapter and its PL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a sapplire cooling function for a better hair removal experience.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body and/or facial hair

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

Non-clinical testing have been conducted to verify that the PL Hair Removal Device meets all design specifications which supports the conclusion that it's substantially equivalent to the predicate devices. The testing results demonstrate that the subject device complies with the following standards:

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;

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 disturbances - Requirements and tests;

IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment;

IEC 60601-2-83 Edition 1.1 2022-12 CONSOLIDATED VERSION Medical electrical equipment - Part 2-83: General requirements for basic safety and essential performance of home light therapy equipment;

IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems;

IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC TS 60601-4-2 Edition 1.0 2024-03 Medical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

The device has been evaluated for biocompatibility as per ISO 10993-1 Fifth edition 2018-08 and tested as per ISO 10993-5 Third edition 2009-06-01, ISO 10993-10 Fourth edition 2021-11 and ISO 10993-23 First edition 2021-01.

The device software has been evaluated as per FDA quidance " Content of Premarket Submissions for Device Software Functions". In order to verify and assure the performance, function and quality of the producted performance verification. The clinical test is not applicable, there's no clinical data.

Based on the above analysis and tests, the subject device is substantially equivalent to the predicate devices.

Key Metrics

Not Found

Predicate Device(s)

K241998, K241834

Reference Device(s)

K241205

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Image /page/0/Picture/0 description: The image shows the date March 19, 2025. The month is spelled out, followed by the day and year. The text is in a simple, sans-serif font and is horizontally aligned. The date is likely intended to represent a specific event or deadline.

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol features a stylized depiction of a human figure, while the text is written in a clear, sans-serif font, with "FDA" in a larger, bolder typeface.

Shenzhen Yang Wo Electronic Co., Ltd. % Riley Chen Registration Engineer Feiying Drug & Medical Consultting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, Guangdong 518052 China

Re: K250171

Trade/Device Name: IPL Hair Removal Device (BE965A, BE965B, BE965C) 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: January 20, 2025 Received: January 21, 2025

Dear Riley Chen:

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 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 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 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-regulatory

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: 2025.03.19 08:49:13
-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

Indications for Use

510(k) Number (if known) K250171

Device Name

IPL Hair Removal Device (BE965A, BE965B, BE965C)

Indications for Use (Describe)

The IPL 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) #:K250171	510(k) Summary			Prepared on: 2025-01-20
Contact Details			21 CFR 807.92(a)(1)
Applicant Name	Shenzhen Yang Wo Electronic Co., Ltd
Applicant Address	101# 3Bldg, The third industry, Shangshi jia Village, Shijia Community,
Matian Street, GuangMing District Shenzhen Guangdong 518106 China
Applicant Contact Telephone	+86-13058187625
Applicant Contact	Mr. Ken Wang
Applicant Contact Email	wangkun@beautigo.com
Correspondent Name	FEIYING DRUG & MEDICAL CONSULTING TECHNICAL SERVICE
Correspondent Address	Rm 2401 Zhenye International Business Center, No. 3101-90,
Qianhai Road Shenzhen Guangdong 518052 China
Correspondent Contact Telephone	+86 13660660449
Correspondent Contact	Ms. Riley Chen
Correspondent Contact Email	c3714930@gmail.com
Device Name
21 CFR 807.92(a)(2)
Device Trade Name	IPL Hair Removal Device (BE965A, BE965B, BE965C)
Common Name	Laser surgical instrument for use in general and plastic surgery and in
dermatology
Classification Name	Light Based Over-The-Counter Hair Removal
Regulation Number	878.4810
Product Code(s)	OHT
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
Predicate #		Predicate Trade Name (Primary Predicate is listed first)		Product Code
K241998		Ice Cooling IPL Hair Removal Device		OHT
K241834		IPL Hair Removal Device		OHT
K241205		Ice Cooling IPL Hair Removal Device		OHT
Device Description Summary				21 CFR 807.92(a)(4)