The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.

Device Description

IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S are a small over-the-counter device for the reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is powered by the external power adaptor or built-in battery and its IPL emission activation is by a switch or auto light emission.

IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, contains a Xenon arc flashlamp, one built-in battery, a capacitive sensor to detect appropriate skin contact, and a skin color sensor to detect the skin color sensor is fixed in "Skin color recognition Window" of IPL Hair Removal device, and the device's skin color sensor automatically detects skin tone for your protection when the device is powered on. If your skin tone is not in tone table suitable for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone. The capacitive sensor is assembled in the device probe of IPL Hair Removal device, 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.

Based on the cooling technology, IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

The IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S can be powered on built-in battery or cable adaptor. The built-in lithium battery can be recharged. When the capacity of battery is low, the battery icon " " " display red on the screen. When the When battery icon " t = " display red with blinking for about 20s the device will turn off. The recharge time of the battery is about 3 hours and when full charged and turn on level 5 to treatment the using time about 45 mins.

When the device is turned on under battery-powered and insert the adaptor with the device, the device will be shut down and to charge. If you want to treatment, you shall turn on the device again with the cable adaptor.

When device is turned on under cable adaptor, then take off the adaptor, the device will be shut down. If you still want to treatment, you shall turn on the device again.

The IPL Hair Removal Device includes main unit (including built-in battery), an adaptor, goggles and shaver.

The device is intended to be used for adults aged over 18.

Principle of operation:

Hair has a growth cycle, which can be roughly divided into incubation period, growth period and decline period. The growth period hair has a complete structure such as hair follicles and hair shafts. The hair in the incubation period and the decline period does not have the hair follicle structure. The removal of excess hair is to take advantage of the characteristics of the anatomical structure of hair. The device based on the IPL technology emits a specific wavelength of the light and delivers the light to the skin. It is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy below the surface of the skin, which disables the hair follicle preventing further growth. Therefore, the device achieves effective hair removal.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for an IPL Hair Removal device. It largely focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical testing and comparison of technical specifications, rather than clinical performance data. Therefore, the information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/human reader performance, is largely absent.

Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:

Acceptance Criteria and Device Performance:

Table of acceptance criteria and reported device performance: This document does not provide specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in hair growth percentage) that an "AI device" would typically have. The acceptance is based on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with safety standards.

Study Proving Device Meets Acceptance Criteria:

1. A table of acceptance criteria and the reported device performance: As noted above, specific performance-based acceptance criteria for hair removal efficacy are not detailed in this 510(k) summary. The acceptance is based on meeting safety standards and having comparable technical characteristics to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document explicitly states: "There was no clinical testing performed." (Page 10, Section 8). This means there is no test set in the sense of a clinical study with patients. The "test set" here refers to non-clinical tests (electrical safety, EMC, biocompatibility, etc.) against recognized standards. Data provenance is not applicable for these non-clinical tests in the way it would be for clinical data.
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 is not applicable as no clinical testing was performed and therefore no "ground truth" established by experts for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable due to the absence of clinical testing.
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: Not applicable. This device is an Intense Pulsed Light (IPL) hair removal device, not an AI diagnostic or assistance system for human readers. It functions autonomously for hair removal.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device's operation is "standalone" in the sense that it doesn't involve an AI algorithm interpreting medical images for a human. It's a direct-use consumer device. Its performance is assessed through its physical characteristics and safety features, not through an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests performed, the "ground truth" is adherence to established engineering and safety standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-5 for cytotoxicity). There's no biological or diagnostic "ground truth" in the typical sense.
8. The sample size for the training set: Not applicable. This is a physical device, and the summary does not mention any AI/machine learning components that would require a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Approval Basis:

The IPL Hair Removal device (models Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over-The-Counter device intended for the removal of unwanted body hair. It uses Intense Pulsed Light (IPL) technology to disable hair follicles.

The FDA's decision of "substantial equivalence" is based on:

Comparison to Predicate Devices: The applicant demonstrates that the subject device has similar technological characteristics (e.g., principle of operation, light source, patient population, environment of use) and indications for use to legally marketed predicate devices (K183217, K223928).
Non-Clinical Testing: The device was tested for safety and effectiveness against a series of recognized consensus standards, including:
- ANSI AAMI ES60601-1 (General safety and essential performance of medical electrical equipment)
- IEC 60601-1-2 (Electromagnetic compatibility)
- ANSI/AAMI HA60601-1-11 (Medical electrical equipment for home healthcare environment)
- IEC 60601-2-83 (Particular requirements for home light therapy equipment)
- IEC 62471 (Photobiological safety)
- ISO 10993-5 (Biocompatibility - in vitro cytotoxicity)
- ISO 10993-10 (Biocompatibility - irritation and skin sensitization)
- IEC 62133-2 (Safety requirements for lithium batteries)
- IEC 62304 (Medical device software life cycle processes)
No Clinical Testing: The document explicitly states that no clinical testing was performed to support the substantial equivalence claim. The assumption is that if the technical specifications and safety features are similar to predicate devices that were previously cleared, and the device meets relevant safety standards, then it is substantially equivalent in terms of safety and effectiveness.

In essence, this FDA 510(k) summary is for a physical medical device, not an AI/ML powered diagnostic or assistance tool. Therefore, the criteria and study methodology you've outlined, which are typical for AI-enabled medical devices, do not apply here.

Summary

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June 26, 2023

ZhongShan Qizhe Technology Co., Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu Guangdong, Guangdong 510663 China

Re: K231215

Trade/Device Name: IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S 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: April 20, 2023 Received: April 28, 2023

Dear You Yijie:

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 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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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K231215

Device Name

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL008S

Indications for Use (Describe)

The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body 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

K231215

1. Submitters Information

Establishment Registration Information

Name:	Zhongshan Qizhe Technology Co., Ltd
Address:	23 Tongji West Road, Nantou Town, Zhongshan City(Room 902, Building 8, Hongji Industrial City Phase II)

Contact Person of applicant:

Name:	Gan Guiping
Address:	23 Tongji West Road,Nantou Town,Zhongshan City(Room 902, Building 8, Hongji Industrial City Phase II)
TEL:	+86 13902957808
Email:	peter@r-d.com.cn

Contact Person of the Submission:

Name:	You Yijie
Address:	RM.406, Building C, Run Science Park, No.18Shenzhou Road, Huangpu, Guangzhou, Guangdong510663 P.R. China
TEL:	(+86)020-82245821
FAX:	(+86)020-82245821
Email:	jet.you@qimmiq-med.com

Date of the summary prepared: Jun. 15, 2023

2. Device Information

Trade Name:	IPL Hair Removal device
Model:	Skin Expert Pro IPL 008Skin Expert Pro IPL 008S
Classification name:	Light Based Over-The-Counter Hair Removal
Common or Usual Name:	Powered Light Based Non-Laser Surgical Instrument WithThermal Effect
Review panel:	General&Plastic Surgery
Product code:	OHT
Regulation Class:	II
Regulation Number:	878.4810

3. Predicate Device Information

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Primary Predicate Device 1

510(k) submitter/holder:	Touchbeauty Beauty & Health(Shenzhen) Co., Ltd
510(K) Number:	K183217
Trade Name	IPL Hair Removal Device
Model	TB-1755
Classification name	Light Based Over-The-Counter HairRemoval
Review panel	General & Plastic Surgery
Product code	OHT, ONF
Regulation Class	II
Regulation Number	878.4810

Primary Predicate Device 2

510(k) submitter/holder:	Shenzhen Fansizhe Science andTechnology Co., Ltd
510(K) Number:	K223928
Trade Name	IPL Hair Removal Device
Model	T016K
Classification name	Laser Surgical Instrument For Use InGeneral And Plastic Surgery And InDermatology
Review panel	General & Plastic Surgery
Product code	OHT
Regulation Class	II
Regulation Number	878.4810

4. Device description

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When device is turned on under cable adaptor, then take off the adaptor, the device will be shut down. If you still want to treatment, you shall turn on the device again.

The IPL Hair Removal Device includes main unit (including built-in battery), an adaptor, goggles and shaver.

The device is intended to be used for adults aged over 18.

Principle of operation:

5. Indications for Use

IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is an Overthe Counter device intended for the removal of unwanted body hair.

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6. Summary of technological characteristics of device compared to the predicate device1 (K183217) and

predicate device2(K160968)

SEComparisons	Subject device(IPL Hair Removal device,model: Skin Expert Pro IPL 008,Skin Expert Pro IPL 008S)	Predicate device 1(IPL Hair Removal Device, Model:TB-1755)	Predicate device 2(IPL Hair Removal Device, Model:T016K)	Discussion ofdifference
510K Number	/	K183217	K223928	/
Classification	21CFR 878.4810	21CFR 878.4810	21CFR 878.4810	Same
Product Code	OHT	OHT, ONF	OHT	Same
FDA Class	II	II	II	Same
Indications for Use	The IPL Hair Removal device(model:Skin Expert Pro IPL 008, Skin ExpertPro IPL 008S) is an Over the Counterdevice intended for the removal ofunwanted body hair.	The IPL Hair Removal device (model:TB-1755) is an Over the Counterdevice intended for the removal ofunwanted body hair.	The IPL Hair Removal Device is anover-the-counter device intended forthe removal of unwanted body hair.	Same
Environment of Use	Home use	Home use	Home use	Same
Design	Hand-hold	Hand-hold	Hand-hold	Same
Patient Population	Adult	Adult	Adult	Same
Material of Patientcontact components	ABS for button, ABS for main housing,PC for Probe cover, PC for Light ExitWindow, PC for Touch key-press ,Sapphire Crystal Cooling Compress	Not public	PC for button, PC for main housingand Probe cover, Sapphire CrystalCooling Compress	Different(Discussion isindicated in D1)
Biocompability testing	1.Type of contact: direct contact forusers and patients.2.Nature of body contact category:Surface Contact class: A (<24 h)3.Meets ISO 10993- 5, ISO 10993-10	Not public	1.Type of contact: direct contact forusers and patients.2.Nature of body contact category:Surface Contact class: A (<24 h)3.Meets ISO 10993- 5, ISO 10993-10	Same
Single Patient,multi-use	Yes	Yes	Yes	Same
Patient Interface	Buttons	Buttons	Buttons	Same
Technology	Intense Pulse Light (IPL)	Intense Pulse Light (IPL)	Intense Pulse Light (IPL)	Same
SEComparisons	Subject device(IPL Hair Removal device,model: Skin Expert Pro IPL 008,Skin Expert Pro IPL 008S)	Predicate device 1(IPL Hair Removal Device, Model:TB-1755)	Predicate device 2(IPL Hair Removal Device, Model:T016K)	Discussion ofdifference
Dimensions	15318552mm for Skin Expert Pro IPL008S14019154mm for Skin Expert Pro IPL008S	18272.469.2mm	9044225mm	Different(Discussion isindicated in D2)
Power source	An external power supply and built-inbattery	An external power supply	An external power supply	Different(Discussion isindicated in D3)
Light source	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Same
Wavelength	510nm~1100nm	510-1100nm	510nm~1200nm	Different(Discussion isindicated in D4)
Spot Size	3.1cm²	3.1 cm²	3.3cm²	Different(Discussion isindicated in D5)
Max. Fluence (J/cm²)	3.8-5.5 J/cm²	3.8-5.2 J/cm²	1.45-5.73J/cm²	Different(Discussion isindicated in D6)
Pulse duration	3ms -9ms	3ms	4ms-12ms	Different(Discussion isindicated in D7)
Output energy	12J -18J	12J-16J	4.8J~18.9J	Different(Discussion isindicated in D8)
PulsingControl	Finger switch	Finger switch	Finger switch	Same
OutputChannel	One channel	One channel	One channel	Same
Delivery	Direct Illumination to Tissue	Direct Illumination to Tissue	Direct Illumination to Tissue	Same
SoftwareControl	Yes	Yes	Yes	Same
Electricalsafety, EMC,BiologicalEvaluation	ANSI AAMI ES60601-1IEC 60601-1-2ANSI/AAMI HA60601-1-11IEC 60601-2-83IEC 62471	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 62471	ANSI AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83IEC 62471	Different(Discussion isindicated in D9)
SEComparisons	Subject device(IPL Hair Removal device,model: Skin Expert Pro IPL 008,Skin Expert Pro IPL 008S)	Predicate device 1(IPL Hair Removal Device, Model:TB-1755)	Predicate device 2(IPL Hair Removal Device, Model:T016K)	Discussion ofdifference
	ISO 10993-5ISO 10993-10IEC 62133-2	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10

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The discussion of differences exist between the subject and predicate devices is listed in following:

D1: The subject device has been validated for cytotoxicy per ISO 1093-5 and Irritation as well as Sensitization per ISO 10993-10 with positive results, therefore, the material difference of subject device with Predicate device 2 (K223928, Model: T016K) do not raise new questions of safety and effectiveness.
D2: The difference of dimensions will not affect the safety and effectiveness.
D3: The subject device has demonstrated electrical safety by ANSI AAM ES6061 1 and ANSI AAM IEC 60601-1-2 testing. Therefore, the difference does not raise the issue of product's safety and effectiveness.
D4: Wavelength of subject device is same with predicate device 2. The sately and effectiveness of the subject device is verified wa tests according to ANSI AAM ES60601-1-2, ANSIAAM H460601-1-11, IEC 62471 and IEC 60601-2-3, so the differences do not affect the safety and effectiveness.
D5. Spot Size of subject device is same with predicate device 2. The safety and effectiveness of the subject device is verified via tests according to ANSI AAM ES60601-1, IEC60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affect the safety and effectiveness.
D6: Max. Fluence of subject device is similar or within devices. The lower linit value of subject device is the same with predicate device 1, the range of subject device is covered by predicate device 2. The subject device is verified via tests according to ANSI AAM ES6001-1, IEC60601-1-2, ANSI/AAM HA60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affectiveness.
DT: Pulse duration of subject devices. The lower limit value of subject device is the same with predicate device 1, and the Pulse duration of subject device is similar with the range of predice 2. The safety and effectiveness of the subject device is verified wa tests according to ANSI AAM ES60601-1, IEC60601-1-2, ANSIAAM HA60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affectiveness.
D8: Output energy of subject device', and the range of subject device is covered by pedicate device 2. The safety and effectiveness of the subject device is verified via tests acording to ANSI AAM ES6061-1-2, ANSIAAMI HA60601-1-11, IEC 62471 and IEC 6001-2-83, so the differences do not affect the safety and effectiveness.

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D9: One of IEC 60601-2-83 and IEC 60601-2-57 is applicable for IPL Hair Removal device, so the diffect the safety and effectiveness. The IEC 62133-2 is applicable for the builtin Lithium battery, and subject device is verified via tests according to ANSI AAM ES60601-1, INS/AAM HA60601-1-11, IEC 62471 and IEC 60601-2-83, so the difference does not affect the safety and effectiveness.

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7. Discussion of Non-Clinical Tests Performed for Safety and

effectiveness are as follows

The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1, ANSI/AAMI HA60601-1-11, IEC 62133-2 for safety, IEC 60601-1-2 for electromagnetic compatibility, IEC 60601-2-83:2011 for performance and IEC 62304 for software verification are complied. See below table for details:

Standards	Standards Name
ANSI AAMIES60601-1:2005/(R)2012 A1:2012,C1:2009/(R)2012A2:2010/(R)2012 (Cons. Text)[Incl. AMD2:2021]	Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance
IEC 60601-1-2: 2014	Medical Electrical Equipment -- Part 1-2: General RequirementsFor Basic Safety And Essential Performance -- CollateralStandard: Electromagnetic Disturbances -- Requirements AndTests
ANSI/AAMI HA60601-1-11:2015 + A1:2021	Medical Electrical Equipment - Part 1-2: General RequirementsFor Basic Safety And Essential Performance - CollateralStandard: Electromagnetic Disturbances - Requirements AndTests
IEC 60601-2-83:2019	Medical electrical equipment Part 2-83: Particular requirementsfor the basic safety and essential performance of home lighttherapy equipment
IEC 62471: 2006	Photobiological safety of lamps and lamp systems
ISO 10993-5 Third edition2009-06-01	Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity
ISO 10993-10 Third Edition2010-08-01	Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization
IEC 62133-2 Edition1.0 2017-02	Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealedsecondary cells, and for batteries made from them, for use inportable applications - Part 2: Lithium systems
IEC 62304 Edition 1.1 2015-06CONSOLIDATED VERSION	Medical device software - Software life cycle processes

Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff, May 2005.

8. Discussion of Clinical Accuracy Testing Performed

There was no clinical testing performed.

9. Conclusions

Based on performance testing, comparison and analysis, the subject device IPL Hair Removal device,

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model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, is substantially equivalent to the predicate devices.

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.