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 three models with the same IPL technology for hair removal, which is model LS-T107 and LS-T108. 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.

The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.2cm2 of LS-T106 and LS-T108, 3.7cm2 of LS-T107 that is suitable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc.

The device contains a skin sensor to detect appropriate skin contact, if the light exti is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which will be activated throughout the whole har removal process to cool down the treatment area' s temperature and provide the user with a better using experience.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data from non-clinical testing. It does not present any clinical study data or acceptance criteria related to device efficacy for hair removal based on human trials.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance related to a clinical outcome (e.g., hair reduction percentage).
Sample size and data provenance for a test set for clinical performance.
Number of experts and their qualifications for establishing clinical ground truth.
Adjudication method for a clinical test set.
MRMC comparative effectiveness study results.
Algorithm-only (standalone) performance.
Type of ground truth used for clinical efficacy.
Sample size and ground truth establishment for a training set.

The document primarily covers non-clinical performance data, which includes:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical):

The acceptance criteria for this device are implied by its conformance to various international standards for safety and biocompatibility, as well as the demonstration of similar technological characteristics to predicate devices. The "reported device performance" is framed as successfully meeting these standards and being comparable to the predicate.

Acceptance Criteria Category	Specific Criteria (Implicitly Met by Testing)	Reported Device Performance
Biocompatibility	Device must not cause adverse biological reactions when in contact with the body. Conformance to ISO 10993-5, ISO 10993-10, and ISO 10993-23.	Passed: Testing conducted per ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Skin sensitization), and ISO 10993-23 (Skin irritation). (Section VIII.1)
Electrical Safety & EMC	Device must be electrically safe and comply with electromagnetic compatibility standards for medical electrical equipment, including home healthcare use. Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83.	Passed: Testing performed to and passed the following standards: ANSI AAMI ES60601-1 (Medical electrical equipment for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-1-11 (Home Healthcare Environment), and IEC 60601-2-83 (Basic safety and essential performance of home light therapy equipment). (Section VIII.2)
Eye Safety	Device emissions must meet photobiological safety standards. Conformance to IEC 62471.	Passed: Testing performed to IEC 62471 (Photobiological safety of lamps and lamp systems). (Section VIII.3)
Software V&V	Software must be verified and validated to meet requirements and mitigate hazards, consistent with a moderate level of concern.	Demonstrated: Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated all software requirement specifications are met and all software hazards mitigated to acceptable risk levels. (Section VIII.4)
Technological Equivalence	Key technical specifications (wavelength, energy density, spot size, pulse duration, light source, etc.) must be similar to legally marketed predicate devices, with any differences not raising new safety or effectiveness concerns.	The device's wavelength range (LS-T106: 610-1200nm, LS-T107: 560-1200nm, LS-T108: 470-1200nm) is considered similar to predicates (e.g., predicate device 550-1200nm, reference device 1 470-1200nm). Differences like the min wavelength of LS-T106 being identical to reference device 4's range are noted. (Note 2, Section VII) Energy density (LS-T106: 2.0-4.87J/cm², LS-T107: 2.16-5.18J/cm², LS-T108: 2.0-5.62J/cm²) and output energy are considered similar, accounting for a ±20% error, and falling within the range of predicate and reference devices. (Note 3, Section VII) Spot sizes (LS-T106: 3.2 cm², LS-T107: 3.7 cm², LS-T108: 3.2 cm²) are similar to reference devices (3.0-3.6cm²). (Note 4, Section VII) Pulse durations (LS-T106: 0.64-2.4ms, LS-T107: 7.2-10.8ms, LS-T108: 6.8-10.2ms) are within or overlap with the ranges of predicate and reference devices. (Note 5, Section VII) The differing number of output intensity levels (3 for subject vs. 5-9 for others) is deemed not to raise safety or effectiveness issues due to comparable wavelength, energy, and density, and compliance with relevant standards. (Note 6, Section VII)

Regarding your specific questions related to clinical efficacy studies (which are NOT in this document):

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data for efficacy is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth for efficacy is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or adjudication process is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document does not describe such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device, but a physical hair removal device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no clinical efficacy study reported. For the non-clinical tests, the "ground truth" is defined by the specific requirements and passing criteria of the referenced international standards.
8. The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set of patient data.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided FDA 510(k) summary for the IPL Hair Removal Device focuses on demonstrating substantial equivalence through non-clinical performance data (biocompatibility, electrical safety, eye safety, software validation) and comparison of technological characteristics with legally marketed predicate devices. It does not include any data or studies related to its clinical efficacy in hair removal (e.g., percentage of hair reduction) on human subjects. For medical devices like this, approval based on substantial equivalence often relies on demonstrating that the new device has similar technology and performance/safety characteristics to products already on the market, rather than requiring new clinical efficacy trials if the intended use and technological principles are well-established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 11, 2023

Shenzhen Lescolton Electrical Appliance Co., Ltd. % Gong Youshan 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: K232499

Trade/Device Name: IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) 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 16, 2023 Received: August 17, 2023

Dear Gong Youshan:

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.

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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 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,

Digitally signed by Jianting Jianting Wang -S Wang -S Date: 2023.10.11 12:08:29 -04'00'

For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices

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Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232499

Device Name IPL Hair Removal Device

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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K232499 510(k) Summary

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

Date Prepared: 2023-09-29

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: 518105 Tel.: 400 153 8008

Qixiang Liu Management representative Tel: +86 13530009850 Email: info@lescolton.com

II. Device

Name of Device: IPL Hair Removal Device Model(s): LS-T106, LS-T107,LS-T108 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

A Predicate Device

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Manufacturer	Predicate Device	510(k) Number	Approval Date
ShenzhenJizhimeiTechnology Co., Ltd.	IPL Cooling Hair RemovalDevice, Model(s): NBB01,NBB02	K230360	April 10, 2023

Reference Device1 A

Manufacturer	Reference Device	510(k) Number	Approval Date
ShenzhenTechnologyElectronics Co., Ltd.	BSX IPL Hair Removal Device,Model(s): BSXT101,BSXT102, BSXT103,BSXT105, BSXT106,BSXT108	K230097	April 6, 2023

Reference Device2 A

Manufacturer	Reference Device	510(k) Number	Approval Date
ShenzhenIONKAMedical TechnologyCo., Ltd.	Hand-held IPL device (IPLHome Use Hair RemovalDevice), Model: FZ-608,FZ-608G, FZ-100, FZ-200	K230739	May 26, 2023

A Reference Device3

Manufacturer	Reference Device	510(k) Number	Approval Date
Shenzhen GSD TechCo., Ltd.	Light Based Hair RemovalDevice GP592	K230060	March 3, 2023

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A Reference Device4

Manufacturer	Reference Device	510(k) Number	Approval Date
Shenzhen YuweiElectronic TechnologyCo., Ltd.	IPL Hair Removal Device	K220222	April 26, 2022

IV. Device Description

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
-------	--------------------------	-----------

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LS-T106, LS-T107	Host of machine (including air outlet, treatmentwindow, air inlet, buttons)	PC+ABS
LS-T108	Host of machine (including air outlet, treatmentwindow, air inlet, buttons)	PC+ABS
	Sapphire cold head (within treatment window)	AL2O3

We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section "013 Biocompatibility evaluation report of IPL Hair Removal Device"

VII. Comparison of Technological Characteristics With the Predicate Device

The IPL Hair Removal Device has the same intented 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.

Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices.

Comparison Elements	Subject Device	Predicate Device	ReferenceDevice 1	Reference Device 2	ReferenceDevice 3	ReferenceDevice 4	Remark
510(k) Number	K232499	K230360	K230097	K230739	K230060	K220222	/
Trade name	IPL Hair Removal Device	IPL Cooling HairRemoval Device	IPL HairRemoval Device	Hand-held device (IPL HomeUse Hair Removal Device)	IPL Light BasedHair Removal Device GP592	IPL HairRemoval Device	/
Manufacturer	Shenzhen LescoltonElectrical Appliance Co., Ltd	Shenzhen JizhimeiTechnology Co.,Ltd.	Shenzhen BSXTechnologyElectronics Co.,	Shenzhen IONKAMedical TechnologyCo., Ltd.	Shenzhen GSDTech Co., Ltd.	Shenzhen YuweiElectronic	/
Comparison Elements	Subject Device	Predicate Device	Reference Device 1	Reference Device 2	Reference Device 3	Reference Device 4	Remark
			Ltd.			Technology Co., Ltd.
Regulation number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
Product code	OHT	OHT	OHT	OHT	OHT	OHT	Same
Device classification	Class II	Class II	Class II	Class II	Class II	Class II	Same
Indication for use/ Intended use	The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.	The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.	The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.	IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.	Light based hair removal 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, excluding patients with Fitzpatrick Skin Phototypes VI.	The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.	Same
Comparison Elements	Subject Device	Predicate Device	ReferenceDevice 1	Reference Device 2	ReferenceDevice 3	ReferenceDevice 4	Remark
Prescription or OTC	OTC	OTC	OTC	OTC	OTC	OTC	Same
Applicable skin	Fitzpatrick skin types I-V	Fitzpatrickskintypes I-V	Fitzpatrick SkinTypes I-V	FitzpatrickSkinTypes I-V	FitzpatrickSkin Types I-V	Not publiclyavailable	Same
Dimension	LS-T106:$202.3\pm0.83856.2$ mmLS-T107: $211.563.548.9$mmLS-T108: $177.56740$ mm	NBB01:$47.654.3240$ mmNBB02-MAX:$2357643$ mm	$190 x 70 x 45$mm	FZ-608, FZ-608G:$9814760$ (mm)FZ-100:$1987144$ (mm)FZ-200:$2166852$ (mm)	Not publiclyavailable	Not publiclyavailable	DifferentNote 1
Light source	Intense Pulsed Light	IntensePulsedLight	IntensePulsedLight	Intense Pulsed Light	Intense PulsedLight	Intense PulsedLight	Same
Energy medium	Xenon Arc lamp	Xenon Arc lamp	Xenon Arc lamp	Xenon ArcFlashlamp	Xenon ArcFlashlamp	Xenon ArcFlashlamp	Same
Wavelength range	LS-T106: 610-1200nmLS-T107: 560-1200nmLS-T108: 470-1200nm	550-1200mm	470nm-1200nm	510nm~1200nm	Notpubliclyavailable	610-1100nm	Similar,thewavelengthrange of LS-T106 is withinreferencedevice 1, andtheminimumwavelength(610nm) ofLS-T106 isidentical toreferencedevice 4.Note 2
Comparison Elements	Subject Device	Predicate Device	ReferenceDevice 1	Reference Device 2	ReferenceDevice 3	ReferenceDevice 4	Remark
Energy density	LS-T106: 2.0-4.87J/cm²LS-T107: 2.16-5.18J/cm²LS-T108: 2.0-5.62J/cm²	2~~5J/cm²(applicableformodel NBB01)2~~4J/cm²(applicableformodel NBB02)	Max 5.0 J/cm²	FZ-608, FZ-608G:3.33 J/cm2FZ-100: 5.43 J/cm2FZ-200: 4.5 J/cm2	4.93J/cm2Max	2.2~5.6 J/cm²	Similar, theenergy densityof LS-T106 iswithinpredicatedeviceofmodel NBB01and the minenergy densityof LS-T106 issimilartoreferencedevice 4, themax energydensity of LS-T106 is withinreferencedevice 4.Note 3
Output energy	LS-T106: 8/10/13J (±20%)LS-T107: 10/13/16J (±20%)LS-T108: 8/12/15J (±20%)	Model NBB01:8 ~ 17.05JModel NBB02:7.14 ~ 13.62J	Pure mode:5~~10J (±20%)Armpit mode:6~~10J (±20%)Body mode:6.5~~11J (±20%)Bikini mode:8~~12.5J (±20%)	FZ-608, FZ-608G:Level 1: 4.16JLevel 2: 4.36JLevel 3: 5.1JLevel 4: 6.1JLevel 5: 6.96JLevel 6: 7.96JLevel 7: 8.63JLevel 8: 9.13J	Not publiclyavailable	Level 1: 8.82J(±20%)Level 2:10.09J (±20%)Level 3:12.73J (±20%)Level 4:14.24J (±20%)	Similar,consider theerror ± 20%,the min outputenergy of LS-T106 is 6.4J whichis withinreference
Comparison Elements	Subject Device	Predicate Device	ReferenceDevice 1	Reference Device 2	ReferenceDevice 3	ReferenceDevice 4	Remark
				Level 9: 10.0J		Level 5:16.76J(±20%)	device 1 onarmpit mode;the max outputenergy of LS-T106 is 15.6Jwhich iswithinpredicatedevice onmodel NBB01.Also, theoutput energyis withinreferencedevice 4.Note 3
Spot size	LS-T106: 3.2 cm²LS-T107: 3.7 cm²LS-T108: 3.2 cm²	3.6cm² (applicablefor model NBB01and NBB02)	3.0cm²± 0.5cm²	3.0cm²	1.05cm*2.95cm(3.1cm²)	3.0cm², 4.1cm²	Similar, thespot size ofLS-T106 issimilar toreferencedevice 1, 2, 3and 4.Note 4
Pulse duration	LS-T106: 0.64-2.4msLS-T107: 7.2-10.8msLS-T108: 6.8-10.2ms	6.4-7.2ms	4-10ms	0.5~0.8 ms	1~3 ms	8~14ms	Similar, themin pulseduration ofLS-T106 is
Comparison Elements	Subject Device	Predicate Device	ReferenceDevice 1	Reference Device 2	ReferenceDevice 3	ReferenceDevice 4	Remark
							0.64ms whichis withinreferencedevice 2, themax pulseduration ofLS-T106 is2.4ms which iswithinreferencedevice 3.Note 5
Output intensity level	LS-T106: 3 levelsLS-T107: 3 levelsLS-T108: 3 levels	NBB01: 5 levelsNBB02: 6 levels	5 Levels	FZ-608, FZ-608G: 9levelsFZ-100: 9 levelsFZ-200: 6 levels	Not publiclyavailable	1~5 levels	DifferentNote 6
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes	Yes	Yes	Same
Electrical safety	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83	ANSI AAMIES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83	AAMIANSIES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83	ANSI AAMIES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57	Same
Eye safety	IEC 62471	IEC 62471	IEC 62471	IEC 62471	IEC 62471	IEC 62471	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same
Comparison Elements	Subject Device	Predicate Device	ReferenceDevice 1	Reference Device 2	ReferenceDevice 3	ReferenceDevice 4	Remark
					ISO 10993-23

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Note 1:

Though the dimension is different from the predicate device, this difference is insignificant and do not raise any safety or effectiveness problems.

Note 2:

Though the wavelength of subject device is different from the predicate device, the wavelength of the subject device can be basically covered by the reference device 1's range. The wavelength range of LS-T106 is within reference device 1, and the min wavelength (610mm) of LS-T106 is identical to reference device 4, and they all comply with IEC 60471 requirements, so this difference will not raise any safety or effectiveness issue.

Note 3:

Though the energy density and the output energy of subject device is a little different from the predicate device and reference devices, consider the error ±20%, the energy density and the output device is within the range of the minimum and maximum value of the predicate device and reference devices.

The energy density of LS-T106 is within predicate device of model NBB01, and the min energy density of LS-T106 is similar to reference device 4. the max energy density of LS-T106 is within reference device 4.

The min output energy of LS-T106 is 6.41 which is within reference device 1 of armpit mode; the max output energy of LS-T106 is 1.5.61 which is within predicate device of model NBB01. Also, the output energy is within reference device 4, and they all comply with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.

Note 4:

There is minor difference in spot size between the reference devices. The spot size is related to energy density while the energy density of subject device and predicate device is the same as explained in Note 3, the spot size of LS-T106 is similar to reference device 1, 2, 3 and 4, so this difference is not significant and will not raise any safety or effectiveness issue.

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Note 5:

Though the pulse duration of subject device is different from the predicate device, the range of LS-T107, LS-T108 is within reference device 1. The min pulse duration of LS-T106 is 0.64ms which is within reference device 2, the max pulse duration of LS-T106 is 2.4ms which is within reference device3. In addition, the subject device comply with IEC 60471 requirement, so this difference will not raise any safety or effectiveness issue.

Note 6:

Though the output intensity level of subject device is different from the predicate device and reference devices, the wavelength, output energy and energy density of the subject device can be basically same with predicate devices as explained in Note 3, and they all comply with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.

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 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
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:

ANSI AAMI ES60601-1 Medical electrical equipments for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment Pat 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests

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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 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

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.

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.