IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed 15 models with the same IPL technology for hair removal, which is model LS-T121/12/A/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12 T130/130A/130B, LS-T133/135/136/137, LS-T134/138/139/140. The device 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 activation is by finger switch.

IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 510-1200m and 600-1200mm. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

AI/ML Overview

The provided text is a 510(k) Summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance against acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly for clinical outcomes like hair removal efficacy, is not present. The document primarily details non-clinical testing for safety and electrical characteristics.

Here's a breakdown of the information that is available, and what is not:

1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for clinical performance (e.g., specific hair reduction percentages) and then report performance against those criteria. Instead, it demonstrates compliance with recognized standards for safety and electrical aspects.

However, based on the comparative elements section (pages 7-9), we can infer the acceptance criteria for substantial equivalence are aligned with the predicate device's technical specifications and intended use. The performance data provided is primarily for non-clinical testing, as detailed below:

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Biocompatibility: No cytotoxicity, skin sensitization, or skin irritation. (ISO 10993-5, -10, -23)	Passed all specified biocompatibility tests.
Electrical Safety: Compliance with general and collateral standards for medical electrical equipment, including home healthcare environments and light therapy equipment. (IEC 60601-1, -1-2, -1-11, -2-83)	Passed all specified electrical safety and EMC tests.
Eye Safety: Compliance with photobiological safety standards. (IEC 62471)	Passed the specified eye safety standard.
Software Verification and Validation: Software fulfills requirements and mitigates hazards.	All software requirement specifications met and hazards mitigated to acceptable risk levels.
Technical Specifications (e.g., Wavelength, Energy Density, Spot Size, Pulse Duration): Similar to predicate devices.	Specifications are listed and compared to predicate devices, showing similarities. These implicitly serve as "acceptance criteria" for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided for any clinical performance or efficacy studies. The document only mentions non-clinical (laboratory) testing for biocompatibility, electrical safety, eye safety, and software, which do not typically involve patient "test sets" in the same way clinical studies do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there is no mention of a human-centric "test set" for clinical efficacy or ground truth establishment. The testing described is non-clinical.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This device is an IPL hair removal device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device does not involve an algorithm with "standalone" performance in the context of diagnostic or assistive AI. It is a physical medical device. The "Software Verification and Validation" section confirms the software meets its requirements, which is a form of standalone testing for the software component, but not in the sense of an independent diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted (biocompatibility, electrical safety, eye safety, software), the "ground truth" is defined by the standards themselves. For example, a successful biocompatibility test result (e.g., no cytotoxicity) is the "ground truth" that the device is biocompatible according to the standard. There is no mention of clinical outcomes data for demonstrating hair removal efficacy in this summary.

8. The sample size for the training set
This information is not provided as the document does not describe any machine learning or AI training, nor any clinical trials with a patient training set.

9. How the ground truth for the training set was established
This information is not provided as no training set or machine learning components are described in the summary.

Summary

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Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

July 9, 2024

Shenzhen Lescolton Electrical Appliance Co., Ltd % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, Guangdong 518052 China

Re: K241343

Trade/Device Name: IPL Hair Removal Device (LS-T121A, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138. LS-T139. LS-T140) 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: May 11, 2024 Received: May 13, 2024

Dear Youshan Gong:

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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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.

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-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.

Digitally signed by Yan Fu -S
Yan Fu -S Date: 2024.07.09 09:34:36
-04'00'

for Tanisha Hithe

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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) K241343

Device Name

IPL Hair Removal Device Model(s): LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LS-T130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140

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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K241343 510(k) Summary

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

Date Prepared: 2024-6-17

I. Submitter

Shenzhen Lescolton Electrical Appliance Co., Ltd

Room 301, Building 04, No. A3, Fourth Industrial Zone, Heshuikou Community, Matian Street, Guangdong, China

Post code: 518100 Tel.: 400 153 8008

Qixiang Liu Management representative Tel: +86-13530009850 E-mail: info(@lescolton.com

II. Device

Name of Device: IPL Hair Removal Device Model(s); LS-T121, LS-T121B, LS-T121C, LS-T130, LS-T130A, LS-T130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140 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

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ଚ୍ଚ Predicate Device

■ For LS-T133/135/136/137, LS-T134/138/139/140

Manufacturer	Predicate Device	510(k) Number
Shen Zhen CosBeautyCo., Ltd.	IPL Hair Removal Device JoyVersion	K173813

■ For LS-T121/121A/121B/121C, LS-T130/130A/130B

Manufacturer	Predicate Device	510(k) Number
Shenzhen LescoltonElectrical ApplianceCo., Ltd	IPL Hair Removal Device	K232499

> Reference Device

■ For LS-T133/135/136/137, LS-T134/138/139/140

Manufacturer	Reference Device	510(k) Number
Shenzhen JizhimeiTechnology Co., Ltd.	IPL Cooling Hair RemovalDevice	K230360

■ For LS-T121/121A/121B/121C, LS-T130/130A/130B

Manufacturer	Reference Device	510(k) Number
Shenzhen IONKA	Hand-held IPL device (IPL	K230739
Medical Technology	Home Use Hair Removal

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Manufacturer	Reference Device	510(k) Number
Co., Ltd.	Device

IV. Device Description

IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed 15 models with the same IPL technology for hair removal, which is model LS-T121/12/A/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12 T130/130A/130B, LS-T133/135/136/137, LS-T134/138/139/140. The device 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 activation is by finger switch.

V. Indications for Use

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

VI. Materials

Model	Contacted Component Name	Materials
LS-T121/121A/121B/121C,LS-T130/130A/130B, LS-T133/135/136/137, LS-T134/138/139/140	Host of machine (including air outlet, treatmentwindow, air inlet, buttons)	PC, ABS, PC+ABS,ADC12, Al2O3(fineness>99.995%),PEEK+30%GF,PC2805+POM

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

VII.Comparison of Technological Characteristics With the Predicate Device

The IPL Hair Removal Device has the same intended use as the predicate. The technological characteristics such as wavelength, energy density, spot size and pulse duration, are similar to the predicate devices. Any minor differences between the subject device and the listed predicate device and reference devices of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference devices for its intended use.

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

ComparisonElements	Subject device	Predicate Device	Reference Device
510(k)Number	K241343	K173813	K230360
Tradename	IPL Hair Removal Device	IPL Hair Removal DeviceJoy Version	IPL Cooling HairRemoval Device
Manufacturer	Shenzhen Lescolton ElectricalAppliance Co., Ltd	Shen Zhen CosBeauty Co.,Ltd.	Shenzhen JizhimeiTechnology Co., Ltd.
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Product	OHT	OHT	OHT
ComparisonElements	Subject device	Predicate Device	Reference Device
code
Deviceclassification	Class II	Class II	Class II
Indicationfor use/Intendeduse	The IPL Hair Removal Device isan over-the-counter deviceintended for removal ofunwanted body and/ or facialhair.	The IPL Hair RemovalDevice Joy Version isindicated for the removalof unwanted hair. Thedevice is also indicated forthe permanent reduction inhair regrowth, defined asthe long-term, stablereduction in the number ofhairs regrowing whenmeasured at 6, 9 and 12months after thecompletion of a treatmentregime. The device is usedfor adults with Fitzpatrickskin types I - IV.	The IPL Cooling HairRemoval Device is anover-the-counterdevice intended forremoval of unwantedbody and/or facialhair.
Prescription or OTC	OTC	OTC	OTC
Wavelength range	LS-T133/135/136/137: 510-1200nmLS-T134/138/139/140: 510-1200nm	510nm~1200nm Max	550-1200mm
ComparisonElements	Subject device	Predicate Device	Reference Device
Energydensity	LS-T133/135/136/137: 1.8~$5J/cm^2$LS-T134/138/139/140: 1.7~$4.7J/cm^2$	$5.1 J/cm^2$	2~~5J/cm² (applicablefor model NBB01)2~~4J/cm² (applicablefor model NBB02)
Spot size	LS-T133/135/136/137: $5.2 cm^2$LS-T134/138/139/140: $5.6 cm^2$	Body: 4.2 [cm²], Bikiniarea and Face: 2 [cm²]	$3.6cm^2$ (applicable formodel NBB01 andNBB02)
Pulseduration	LS-T133/135/136/137: 9.20-11.20msLS-T134/138/139/140: 9.20-11.20ms	9.20~11.20milliseconds	6.4-7.2ms

1. For LS-T133/135/136/137, LS-T134/138/139/140

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2. For LS-T121/121A/121B/121C, LS-T130/130A/130B

ComparisonnElements	Subject device	Predicate Device	Reference Device
510(k)Number	K241343	K232499	K230739
Tradename	IPL Hair Removal Device	IPL Hair Removal Device	Hand-held IPL device(IPL Home Use HairRemovalDevice)
Manufactur	Shenzhen Lescolton Electrical	Shenzhen Lescolton	Shenzhen IONKA

ComparisonElements	Subject device	Predicate Device	Reference Device
er	Appliance Co., Ltd	Electrical Appliance Co.,Ltd	Medical TechnologyCo., Ltd.
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Productcode	OHT	OHT	OHT
Deviceclassification	Class II	Class II	Class II
Indicationfor use/Intendeduse	The IPL Hair Removal Device isan over-the-counter deviceintended for removal ofunwanted body and/ or facialhair.	The IPL Hair RemovalDevice is an over-the-counter device intendedfor removal of unwantedbody and/ or facial hair.	IPL Home Use HairRemoval Device isindicated for theremoval of unwantedhair. The device isalso indicatedfor the permanentreduction in hairregrowth, defined asthe long-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime.
ComparisonElements	Subject device	Predicate Device	Reference Device
Prescription or OTC	OTC	OTC	OTC
Wavelength range	LS-T121: 600-1200nmLS-T130: 600-1200nm	LS-T106: 610-1200nmLS-T107: 560-1200nmLS-T108: 470-1200nm	510nm〜1200nm
Energydensity	LS-T121: 2.5-6.0J/cm2LS-T130: 1.3〜5.7 J/cm2	LS-T106: 2.0-4.87J/cm2LS-T107: 2.16-5.18J/cm2LS-T108: 2.0-5.62J/cm2	FZ-608, FZ-608G:3.33 J/cm2FZ-100: 5.43 J/cm2FZ-200: 4.5 J/cm2
Spot size	LS-T121: 3.2 cm2LS-T130: 3.6 cm2	LS-T106: 3.2 cm²LS-T107: 3.7 cm²LS-T108: 3.2 cm²	3.0cm²
Pulseduration	LS-T121: 9-12msLS-T130: 0.5-5ms	LS-T106: 0.64-2.4msLS-T107: 7.2-10.8msLS-T108: 6.8-10.2ms	0.5~0.8 ms

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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 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 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

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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, the following standards:

IEC 60601-1:2005/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014+A1:2020 Medical electrical equipments for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11:2015+A1:2020 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirent for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
IEC 60601-2-83:2019 Medical electrical equipments for the basic safety and essential performance of home light therapy equipment

3) Eye Safety

IEC 62471:2006 Photobiological safety of lamps and lamp
systems 4) Software Verification and Validation

Software documentation consistent with basic documentation 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.

IX. Conclusions

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject 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.