The Intense pulsed light device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G twelve models. All have adopted the same structure design, consisting of Intense pulsed light device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly product size, appearance, sapphire, skin color recognition function and enclosure color, DE01A series means without sapphire and skin color recognition function. DE01B series means with sapphire, but without skin color recognition function. DE01C series means with sapphire and skin color recognition function. DE02A series means without sapphire and skin color recognition function. DE02B series means with sapphire, but without skin color recognition function. DE02C series means with sapphire and skin color recognition function. Letter -B the enclosure color is blue, letter -G is green, which do not affect the intended use.

AI/ML Overview

The provided text is a 510(k) summary for an Intense Pulsed Light (IPL) device intended for over-the-counter hair removal. It details the device's characteristics, comparison with predicate devices, and performance data submitted to support substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of advanced AI/ML performance metrics (e.g., accuracy, sensitivity, specificity). The performance data shared are related to:

Biocompatibility Testing: Ensuring the device materials are safe for human contact.
Electrical Safety and EMC: Verifying the device meets electrical safety and electromagnetic compatibility standards.
Eye Safety: Confirming the device is safe for eye exposure.
Software Verification and Validation: Demonstrating that software meets requirements and mitigates hazards.
Usability: Evaluating and verifying the product's usability.

These are standard regulatory requirements for medical devices, particularly for consumer-grade devices like the IPL hair removal system. They are not AI/ML performance metrics.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about a study proving this in the context of an AI-driven device, because the provided text is for a physical IPL device and does not mention any AI/ML components or associated performance studies. The request's questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are specific to the evaluation of AI/ML algorithms in medical imaging or diagnostics, which is not the subject of this 510(k) submission.

Summary

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July 31, 2023

Zhuzhou Goldenhot Medical Technology Co., Ltd. % Candice Qui Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China

Re: K231613

Trade/Device Name: Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. 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: June 1, 2023 Received: June 2, 2023

Dear Candice Qui:

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

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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.

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,

Jianting Wang -S

Jianting Wang 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) K231613

Device Name

Intense pulsed light device Model(s): DE01A-B, DE01A-G, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02B-G, DE02C-B, DE02C-G

Indications for Use (Describe)

The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial harr.

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 - K231613

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

I. Submitter

Zhuzhou Goldenhot Medical Technology Co.,Ltd.

Room 301, Plant C-3, Phase 5, Xinma Power Innovation Park, No. 889, Xianyue huan Road, Majiahe Street,Tianyuan District, Zhuzhou City, Hunan Province, China Post code: 412007 Tel.: +86 0731 28589339 Liu Xianwu Deputy Manager Tel: +86 13808497058 Email: 2850977367@qq.com

II. Device

Name of Device: Intense pulsed light device Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation 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 and Reference Device

Predicate device:

Manufacturer	Predicate Device	510(k) Number	Approval Date
Shenzhen Fansizhe ScienceAnd Technology Co., Ltd	Intense Pulsed Light (IPL) System(T023K, T023A, T023B,T023C, T023D, T023E,T021K, T021A, T001A,T001B, T001M, T001N,T011C, T016K)	K223928	March 28, 2023

Reference device:

Manufacturer	Reference Device	510(k) Number	Approval Date
ShenzhenJunbobeautyTechnology Co., Ltd	IPL HAIR REMOVALHANDSET (IPL-666)	K220669	May 16, 2022

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IV. Device Description

V. Indications for Use

The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.

VI. Materials

Componentname	Material of Component	Body Contact Category	Contact Duration
Intense pulsedlight device(Enclosure)	ABS, PC, POM	Surface-contactingdevice: Intact skin	Less than 24 hours

We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section 16 "Biocompatibility Discussion".

VII.Comparison of Technological Characteristics With the Predicate Device

The Intense pulsed light device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate device and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference device for its intended use. Therefore, the Intense pulsed light device may be found substantially equivalent to its predicate device and reference device.

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Intense pulsed light device is compared with the following Predicate Device and Reference Device in terms of intended use, design, material, specifications, and performance:

ComparisonElements	Subject Device	Predicate Device	Reference Device	Remark
510(k)Number	Pending	K223928	K220669	/
Trade name	Intense pulsed lightdeviceModel: DE01A-B,DE01A-G, DE01B-B, DE01B-G,DE01C-B, DE01C-G, DE02A-B,DE02A-G, DE02B-B, DE02B-G,DE02C-B, DE02C-G	Intense Pulsed Light(IPL) SystemModel: T023K,T023A, T023B,T023C, T023D,T023E, T021K,T021A, T001A,T001B, T001M,T001N, T011C,T016K	IPL HAIR REMOVALHANDSETModel: IPL-666	/
Manufacturer	Zhuzhou GoldenhotMedicalTechnologyCo.,Ltd	ShenzhenFansizheScienceAndTechnology Co., Ltd	Shenzhen JunbobeautyTechnology Co., Ltd	/
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
Product code	OHT	OHT	OHT	Same
Deviceclassification	Class II	Class II	Class II	Same
Indication foruse/ Intendeduse	The Intense pulsedlight device is anover-the-counterdevice, intended forremoval ofunwanted bodyand/or facial hair.	The Intense PulsedLight (IPL) Systemis an over-the-counter deviceintended for theremoval of unwantedbody hair.	IPL HAIR REMOVALHANDSET is an over-the-counter deviceintended for removal ofunwanted body and/orfacial hair.	Same
Prescriptionor OTC	OTC	OTC	OTC	Same
Applicableskin	FitzpatrickSkinTypes I-V	FitzpatrickSkinPhototypes I-V	Fitzpatrick skin types I- V	Same
ComparisonElements	Subject Device	Predicate Device	Reference Device	Remark
Treatmentarea	Small areas such asbikini line.Large areas such asarms, legs.	Used on facial hairbelow the chin line,arms, legs,underarms, bikiniline.	Used on facial hairbelow the chin line,arms, legs, underarms,bikini line.	Similar
Device design
Power source	An external powersupply	An external powersupply	Supplied by externaladapter	Same
Power supply	Input: AC 100 ~240V , 50/60 Hz,1.0AOutput: 24V==2.5A	Unknown	100-240V AC Input12V3A DC Output	Different
Dimension	DE01A-B, DE01A-G:218(W)x77(H)x97(L)mmDE01B-B, DE01B-G,DE01C-B,DE01C-G:218(W)x77(H)x103(L)mm DE02A-B,DE02A-G:178(W)x67(H)x150(L)mmDE02B-B, DE02B-G,DE02C-B,DE02C-G:183(W)x67(H)x150(L)mm	116217.842mmfor T023K, T023A,T023B, T023C,T023D and T023E73.281.1202.2mmfor T021K andT021A18278151mm forT001A, T001B,T001M and T001N21113860mm forT011C9044225mm forT016K	124 x83 x 48.5mm	Different
Sterilization	Not required	Not required	Not required	Same
Output specification
Light source	Intense PulsedLight	Intense Pulsed Light	Intense Pulsed Light	Same
Energymedium	Xenon Flashlamp	XenonFlashlamp Arc	Xenon Quartz Tube	Similar
Wavelengthrange	510-1200nm	510-1200nm	470-1100 nm	Similar
Energydensity	Body mode: 1.2 ~4.1 J/cm²	5.5J/cm2 for T023K,	1.3-2.49 J/cm²	Similar
ComparisonElements	Subject Device	Predicate Device	Reference Device	Remark
	Face mode : 1.2 ~4.1 J/cm2Bikini mode: 1.2 ~4.1 J/cm2	T023A, T023B,T023C, T023D andT023E,4.8J/cm2 for T021Kand T021A,4.7J/cm2 for T001A,T001B, T001M andT001N,5.75J/cm2 forT011C,5.73J/cm2 forT016K
Output energy	Body: 6.4-14.0 JFace: 5.6-11.9 JBikini line: 5.7-12.8 J	6.5J ~ 16.6J forT023K, T023A,T023B, T023C,T023D and T023E5.6J ~ 14.5J forT021K and T021A7.3J ~ 18.6J forT001A, T001B,T001M and T001N5.3 J ~ 20.7J forT011C4.8J ~ 18.9J forT016K	Level 1: 3.92JLevel 2: 4.72JLevel 3: 5.62JLevel 4: 6.49JLevel 5: 7.48J	Similar
Spot size	3.9 cm²	3.0cm² for T023K,T023A,T023B,T023C,T023D,T023E, T021K andT021A,4.0cm² for T001A,T001B, T001M andT001N,3.6cm² for T011C,3.3cm² for T016K	3 cm²	Similar
Pulse duration	Body mode:7.0±2.0 ~ 9.0±2.0msFace mode: 8.0±2.0~ 10.0±2.0 ms	4 ~ 12ms	11.5-15 ms	Similar
ComparisonElements	Subject Device	Predicate Device	Reference Device	Remark
	Bikini mode:$9.0\pm2.0 ~ 11.0\pm2.0$ms
Pulsingcontrol	Finger switch	Finger switch	Finger switch	Same
Deliverydevice	Direct illumination to tissue	Direct illumination to tissue	Direct illumination to tissue	Same
Outputintensity level	5 Levels	Unknown	5 Levels	Same
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Same
Additional features
Electricalsafety	IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11IEC 60601-2-83	ANSI AAMIES60601-1IEC 60601-1-2IEC 60601-1-11IEC60601-2-83	IEC 60601-1,IEC 60601-1-2IEC 60601-1-11,IEC60601-2-83,IEC 62471	Same
Eye safety	IEC 62471	IEC 62471	IEC 62471	Same
Biocompatibility	ISO 10993-5ISO 10993-10ISO 10993-23	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

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VIII. 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 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 September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:

A 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

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ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation

2) Electrical Safety and EMC

Electrical safety and EMC testing was performed to, and passed, as per 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
A ANSI AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
A IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
A IEC 60601-1-11 Medical electrical equipment - Part 1-11: 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 60601-2-83 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

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.

5) Usability

The product usability has been evaluated and verified according to the following FDA guidance > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016

IX. Conclusions

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Intense pulsed light device is as safe, as effective, and performs as well as the legally marketed predicate device and reference device.

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.