The Lumilisse IPL Hair Remover (Figure 11.1) is a hair-removal device that eliminates unwanted hair from the body (legs and arms), and from more sensitive areas (underarms, bikini line, lower half of the face - below the cheekbones) using intense pulse light technology.

The Lumilisse IPL Hair Remover is an Intense Pulsed Light (IPL) system consisting of:

. Handset - contained within the handset is the High Voltage Capacitor, Capacitor Charger, Control Electronics and Firmware, Quartz Light Tube, Cooling System, Skin Tone and Skin Contact Sensors and the firmware for operation and safety.
External Power Supply – used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a much lower DC value. This power supply unit is an "off-theshelf" component which meets all the relevant electrical safety standards.
Skin Color Sensor System - For effective and safe treatment, the Lumilisse IPL Hair Remover is equipped with the Skin Sensor System, a skin color detection system that automatically regulates the light intensity applied to the skin.
. Levels of Intensity - The Lumilisse IPL Hair Remover features 5 levels of intensity, running from the lowest (level 1) to the highest (level of intensity indicates the intensity of the pulsed light applied to the skin when using the Lumilisse Hair Remover.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Lumilisse IPL Hair Remover. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing rigorous clinical trial data with predefined acceptance criteria and detailed statistical analyses. While a clinical study was conducted, it is not presented in the format of a typical clinical trial report with specific acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria and the study proving the device meets them cannot be fully extracted from the provided text.

Here's a breakdown of what can be inferred and what information is missing:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantified acceptance criteria (e.g., a specific percentage of hair reduction to be achieved) in a table format. The conclusion of the clinical study states:

"Each of the two units had a significant effect in lowering the amount and density of hairs in regions tested."
"The dermatological evaluation was positive for safety, and the final study results, for the large majority of the test Subjects, was that the units had the desired effects."
"The comparative study concluded the Lumilisse Hair Remover reduction results last for 6 months with over 75% less hair on legs and concluded cutaneous acceptability for legs, underarms and half-upper lip."
"The study concluded Lumilisse Hair Removal Systems as safe and effective when used according to instructions."

From this, we can infer the following as performance outcomes, but not explicitly stated as acceptance criteria that were defined beforehand:

Inferred Performance Metric	Reported Device Performance
Hair Reduction	Significant reduction in amount and density of hairs; over 75% less hair on legs lasting for 6 months.
Safety	Only safety events appeared unrelated to the units themselves; dermatological evaluation positive for safety; concluded safe.
Cutaneous Acceptability	Concluded cutaneous acceptability for legs, underarms, and half-upper lip.
Effectiveness	Concluded effective for hair removal.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The text mentions "the large majority of the test Subjects" but does not give a number.
Data Provenance: The study compared the "G920 and G930 IPL Hair Remover (European pre-cursor to the IPL960F Lumilisse Hair Remover)". This suggests the data might be retrospective from a European market launch or a study conducted for European regulatory purposes, but this is an inference. It doesn't explicitly state "retrospective or prospective" or the specific "country of origin of the data" beyond "European pre-cursor".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The assessment was a "dermatological evaluation," implying dermatologists were involved, but details on their number or qualifications (e.g., years of experience) are missing.

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 is not applicable. The device is an IPL hair remover, not an AI-assisted diagnostic or imaging device used by human readers. The study performed was a clinical study on hair reduction and cutaneous acceptability.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical IPL hair remover, not a software algorithm. Its performance is inherent to the device itself when used by a person.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for effectiveness appears to be clinical outcome data (reduction in hair amount and density, duration of hair reduction, and cutaneous acceptability) assessed via direct observation.

8. The sample size for the training set

This is not applicable. As a physical device, there isn't a "training set" in the context of machine learning algorithms.

9. How the ground truth for the training set was established

This is not applicable.

In summary, the provided FDA 510(k) summary focuses on substantial equivalence based on technological characteristics and a general review of non-clinical and limited clinical performance data. It does not contain the detailed structure of a typical clinical study report that would specify exact acceptance criteria, sample sizes beyond general statements, and granular details about expert involvement or ground truth establishment as would be present for software or AI medical devices.

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). 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.

January 18, 2018

Conair Corporation % Mr. E.J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K172791

Trade/Device Name: Lumilisse IPL Hair Remover 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: October 20, 2017 Received: October 20, 2017

Dear Mr. Smith:

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. 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.

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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -ડર્ For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172791

Device Name Lumilisse Hair Removal System

Indications for Use (Describe)

The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Sponsor:	Conair Corporation
Address:	One Cummings Point RoadStamford, CT 06902
Telephone Number:	203-975-4617
Contact Person:	Mike CantrellRegulatory Compliance
Email:	mike_cantrell@conair.com
Summary Preparation Date:	January 18, 2018
Device Name:
Classification Name:	Light based OTC Hair Remover
Common/Usual Name:	Light based OTC Hair Remover
Proprietary Name:	Lumilisse IPL Hair Remover
Establishment Registration:	1222304
Classification:	Class II
Product Code:	OHT
Code of Federal regulation:	21 CFR 878.4810
Review Panel:	General Surgery Devices Branch One - Light Based/Laser

Predicate Device:

Predicate	Manufacturer	Brand Name	510(k) Number
Primary	Home Skinovations Ltd.	Silk'n Flash N Go	K103184
Reference	Syneron Beauty Ltd.	mē	K131649
Reference	CyDen Ltd.	iPulse SmoothskinGold	K160968

Device Description:

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The Lumilisse IPL Hair Remover is an Intense Pulsed Light (IPL) system consisting of:

. Handset - contained within the handset is the High Voltage Capacitor, Capacitor Charger, Control Electronics and Firmware, Quartz Light Tube, Cooling System, Skin Tone and Skin Contact Sensors and the firmware for operation and safety.
External Power Supply – used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a much lower DC value. This power supply unit is an "off-theshelf" component which meets all the relevant electrical safety standards.
Skin Color Sensor System - For effective and safe treatment, the Lumilisse IPL Hair Remover is equipped with the Skin Sensor System, a skin color detection system that automatically regulates the light intensity applied to the skin.
. Levels of Intensity - The Lumilisse IPL Hair Remover features 5 levels of intensity, running from the lowest (level 1) to the highest (level of intensity indicates the intensity of the pulsed light applied to the skin when using the Lumilisse Hair Remover.

The Lumilisse Hair Remover can be used by men and women aged 21 and older.

Device Indications for Use:

The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.

Discussion of Technological Characteristics:

Discussion of Similarities

The Lumilisse IPL Hair Remover and the predicate devices have IPL technology, capacitancebased skin contact sensor such that if the flash port is not in direct contact with the skin (covering the entire port) the unit will not flash, skin tone sensors, pulse durations for use, use environment, user group, power source, operating/storage temperature and relative humidity conditions. The Lumilisse IPL Hair Remover has the identical wavelengths as the mē.

Discussion of Differences K103184:

The Lumilisse IPL Hair Remover lowest light intensity reading is 2.0 J/cm² versus predicate's lowest light intensity of 3.0 - 5.0 J/cm² and the Lumilisse IPL Hair Remover wavelength range is 550 nm - 1200 nm versus the predicate device wavelength range of 475 nm - 1200 nm. The differences in light intensity and wavelength raise no new issues of safety and effectiveness.

Discussion of Differences K131649:

The Lumilisse IPL Hair Remover maximum light intensity is 4.5 J/cm² versus the predicate's maximum light intensity of 4 J/cm² and the difference raises no new issues of safety and effectiveness.

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Discussion K160968:

The Lumilisse IPL Hair Remover has a wavelength of 550-1200m and the predicate has a wavelength of 510-1100nm. The Lumilisse IPL Hair Remover has a light intensity of 2.0 J/cm² and the predicate has a maximum optical of 3-6 J/cm². The Lumilisse IPL Hair Remover automatically controls the repetition rate for Level 1.6 seconds and Level 5, 1 pulse every 3.5 seconds, whereas, the predicate states their repetition rate as manually, 1 pulse every 1-2 seconds. The differences in wavelength, light intensive no new issues of safety and effectiveness.

Parameters	ConairLumilisse IPL HairRemover	Home SkinovationsLtdSilk'n Flash N Go	Syneron Beauty Ltd.mē	CyDen Ltd	Comments
510 (k) Number4	The Lumilisse IPL(Intense PulsedLight) HairRemover is anover-the-counterdeviceintended for theremoval ofunwanted hair.	K103184Flash N Go is anover the counterdevice intended forthe removal ofunwanted hair.Flash N Go is alsointended forpermanentreduction in hairregrowth definedas long-term,stable reduction inhair countsfollowing atreatment regime.	K131649The mē Is an over-the-counter deviceIntended for theremoval of unwantedhair. Mē Is alsoIntended forpermanent reductionIn hair growthfollowing an Initialtreatment regimenwith or withoutmaintenance whenmeasured at 6, 9, and12 months.	K160968The iPulseSmoothSkin GoldHair Removal Systemis indicated for theremoval ofunwanted hair. TheiPulse SmoothskinGold is also indicatedfor the permanentreduction in hairregrowth, defined asthe long-term, stablereduction in thenumberof hairs regrowingwhen measured at 6,9 and 12 monthsafter the completionof atreatment regime.	SubstantiallyEquivalent
Indications for Use
Use Environment	Home Use	Home Use	Home Use	Home Use	Substantially
					Equivalent
Wavelength	550-1200 nm(when using withbody lens)600-1200 nm(when using withfacial lens)	475-1200 nm	550-1200 nm	510-1100nm	Different
Light Intensity	Level 1: 2.0 J/cm²Level 2: 3.0 J/cm²Level 3: 3.5 J/cm²Level 4: 4.0 J/cm²Level 5: 4.5 J/cm²	Level 1: 3-5 J/cm²	Maximum Optical= 4 J/cm²	3 - 6 J/cm²	Different
Repetition Rate	At Level 1, 1 pulseevery 1.6 secondsAt Level 5, 1 pulseevery 3.5 seconds	1 pulse every 3.5 seconds	1 pulse every 0.9 seconds	Manually, 1 pulseevery 1-2 seconds	Different
Power Source	100-240 VAC, 3.5 A	100-240V, 2A	100-240 VAC, 50-60 Hz	110V or 230V,50/60Hz	SubstantiallyEquivalent
		Temperature
Operating	+10°C to +35°C	10°C to 40°C	10°C - 30°	15°C - 30°C	Substantially
Storage	-40°C to +70°C	-40°C to +70°C	10°C - 55°C	85% non-condensing	Equivalent
		Humidity
Operating	30% to 75% RH	30% to 75% RH	Up to 80% at 37°C	N/A	Substantially
Storage	30% to 75% RH	30% to 90% RH	90% at 55°C	N/A	Equivalent
		Atmospheric Pressure
Operating	700 to 1060hPa	700 to 1060hPa	700-1060hPa	N/A	SubstantiallyEquivalent

Predicate Product Comparison Table

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Non-clinical Performance Data:

ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin ● Sensitization
. IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
. IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
. 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 60601-2-57 Medical electrical equipment - part 2-57: particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
IEC 62471 Photobiological safety of lamps and lamp systems
FCC Subpart 15B Unintentional Radiators
. ISO 14971 Medical Devices – Applications of Risk Management to Medical Devices
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "Moderate" level of concern.

Usability Study

A Human Factors Usability study was conducted using 20 participants to demonstrate the participants were capable of reading the instruction manual and were then able to use the Lumilisse IPL Hair Remover correctly. The Conair Lumilisse IPL Hair Remover was found to be safe and effective for the intended users, uses and use environments based on the results of our simulated use study, biocompatibility testing,

Clinical Study:

A clinical study was conducted comparing the G920 and G930 IPL Hair Remover (European pre-cursor to the IPL960F Lumilisse Hair Remover) hand-held systems to evaluate the in-vivo efficacy and cutaneous acceptability on the legs and cutaneous acceptability for the underarms and half-upper lips.

Each of the two units had a significant effect in lowering the amount and density of hairs in regions tested. The only safety events appear to be unrelated to the units, themselves. The dermatological evaluation was positive for safety, and the final study results, for the large majority of the test Subjects, was that the units had the desired effects.

The comparative study concluded the Lumilisse Hair Remover reduction results last for 6 months with over 75% less hair on legs and concluded cutaneous acceptability for legs, underarms and half-upper lip.

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The study concluded Lumilisse Hair Removal Systems as safe and effective when used according to instructions.

Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Conair concludes that the Lumilisse IPL Hair Removal System is substantially equivalent to predicate devices with regard to safety and effectiveness.

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.