The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold 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.

Device Description

The iPulse SmoothSkin Hair Removal System is an intense pulsed light (IPL) system consisting of:

Handset - contained within the handset is the Capacitor, Capacitor Charger, Control electronics, Optics (Lamp, Filter, Reflector, Light Pipe), Trigger mechanism and Skin Tone / proximity Sensors (STS);

External Power Supply - used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a lower DC value, typically 24V. This power supply unit is an "off-the-shelf" component which meets all the relevant electrical safety standards.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (iPulse SmoothSkin Gold)
Hair Reduction at 6 months Post Treatment	43.9%
Hair Reduction at 12 months Post Treatment	36.0%
% of Subjects met success (>30% hair reduction) on all body areas at 12 months post-treatment	66.7%

2. Sample Size and Data Provenance for Test Set:

Sample Size: 50 subjects for the 6-month post-treatment evaluation, and 33 subjects for the 12-month post-treatment evaluation.
Data Provenance: Prospective, single-center clinical study. The country of origin of the data is not explicitly stated, but the company (iPulse Limited) is based in Swansea, Wales, United Kingdom.

3. Number of Experts and Qualifications for Ground Truth:

The ground truth for hair count was established by 2 independent assessors.
Their specific qualifications (e.g., radiologist with X years of experience) are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set:

The results from the 2 independent assessors were averaged. This implies a form of consensus or averaging method rather than a strict 2+1 or 3+1 adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on device performance for hair reduction, not on human reader improvement with or without AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was done. The clinical testing assessed the iPulse SmoothSkin Gold Hair Removal System directly for its efficacy in hair reduction without human-in-the-loop performance in terms of interpretation or decision-making. The device is an over-the-counter hair removal system.

7. Type of Ground Truth Used:

Expert consensus (averaged hair counts) based on direct physiological measurements (hair counts) and clinical photographs.

8. Sample Size for the Training Set:

The provided text does not explicitly mention a separate "training set" or its sample size. The clinical study described appears to be the primary efficacy evaluation without a distinct training phase in the context of an AI/algorithm.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as a separate training set is not explicitly described for an AI/algorithm. The ground truth for the clinical efficacy evaluation (the device's performance) was established by the averaged hair counts from 2 independent assessors.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 18, 2015

iPulse Limited Dr. Michael Kiernan Chief Scientific Officer Technium 2, Kings Road, The Docks Swansea, Wales SA1 8PJ, Wales, United Kingdom

Re: K143003 Trade Name: iPulse SmoothSkin Gold Hair Removal System 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, ONX, GEX Dated: May 15, 2015 Received: May 18, 2015

Dear Dr. Kiernan:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

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) K143003

Device Name

iPulse SmoothSkin Gold Hair Removal System

Indications for Use (Describe)

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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FOR FDA USE ONLY

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3.0 510(K) SUMMARY

Submission Date:	15th October 2014			PREDICATE DEVICES			DEVICE
Submitter Information			Device Name	iPulse Hair RemovalSystem	Shaser HRS2 IPL	mē	iPulse Smooth SkinGold
Company Name:Company Address:	iPulse Limited.Technium 2, Kings Road, Swansea, Wales, UK SA1 8PJ		K Number	K130315	K120080	K131649	K143003
Contact Person:	Dr Mike KiernanUK +44 1792 485 519mkiernan@cyden.com		Manufacturer	CyDen Ltd	ShaserInc	Syneron Beauty Ltd	iPulse Ltd
Device Information			Energy Medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp
Trade Name:	iPulse SmoothSkin Gold Hair Removal System		WavelengthRange	530-1100nm	650-1100nm*	550-1200nm	510-1100nm
Common Name:	Light based over the counter hair removal system		Pulse Duration	Variable -Single pulse25milliseconds.toDouble Pulse 20mson, 60 ms off.	30 milliseconds	~5ms	2ms to 10ms
Classification Name:	Laser surgical instrument for use in general and plasticsurgery and dermatology		Energy Density	7-10J/cm²	9J/cm²	Up to 9J/cm²	3-6J/cm²
Device Class:	21 CFR 878.4810		Spot Size	3cm² (1.3cm by 2.4cm)	2cm² (1cm by 2cm)	3.3cm2 (3.3cm by1.0cm)	3cm²
Predicate Devices:	iPulse Smoothskin Hair Removal SystemK130315CyDen Limited		Delivery Device	Direct IlluminationTo Tissue	Direct Illumination toTissue	Direct Illumination toTissue	Direct Illumination toTissue
	The Shaser HRS2 IPL Hair Removal SystemK120080ShaserInc		Pulsing Control	Finger switch	Finger switch	Finger Switch	Finger switch
	mēK131649Syneron Beauty Ltd		Skin Tone Sensor	OpticalMeasurementRemovable fromBase Unit.Sensor moveable totreatment site	OpticalMeasurementIntegral to Base UnitSensor fixed in baseunit, treatment sitemoved to sensor	Electrical Contact	OpticalMeasurementIntegral to device.Continuousmeasurement.
SpecificIndications forUse	The iPulse HairRemoval System isan Over-the-counterdevice intended forthe removal ofunwanted hair.	The Shaser HRS2 isan Over-the-counterdevice intended forthe removal ofunwanted hair. It isalso intended forpermanent reductionin unwanted hair.Permanent hairreduction is definedas the long-termstable reduction inthe numbers of hairsregrowing whenmeasured at 6,9 and12 months after thecompletion of atreatment regimen.	The me is an over-the-counter deviceindicated for theremoval of unwantedhair. Me is alsointended forpermanent in hairgrowth following aninitial treatmentregimen with orwithout maintenancewhen measured at6,9 and 12 months.	The iPulseSmoothSkin GoldHair Removal Systemis indicated for theremoval of unwantedhair. The iPulseSmoothskin Gold isalso indicated for thepermanent reductionin hair regrowth,defined as the long-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime.
Table 1: Predicate Device Comparison

A comparison of the key technological characteristics of the iPulse Smoothskin Gold System to the predicate devices is provided in Table 1.

CONFIDENTIAL

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Device Description

The iPulse SmoothSkin Hair Removal System is an intense pulsed light (IPL) system consisting of:

Intended Use

The iPulse SmoothSkin Gold Hair Removal System is an over the counter device intended for the removal of unwanted hair.

Indications for Use

Performance Data - Non Clinical

Nonclinical, clinical and usability testing has been completed on the iPulse SmoothSkin Hair Removal System. Nonclinical testing included biocompatibility, electrical safety and software testing.

Usability testing was completed in 24 subjects to evaluate device human factors and label comprehension.

Performance Data - Clinical

Clinical testing was conducted in 50 subjects at a single treatment center. Each subject received 12 weekly treatments to the selected body location. Prior to treatment the site was shaved and any hair trimmings removed. The treatment was performed by a suitable operator to ensure consistency of coverage thus enabling accurate efficacy determination. The device output setting for each subject was determined by the measured skin tone at the actual treatment site.

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Hair counts were performed on a fixed area located at the center of the treatment site using templates and skin landmarks. All treatment sites were photographed prior to each treatment and at the review point. All subjects were shaved one week prior to both baseline and the 6 and 12 month review points thus ensuring hair count consistency.

Hair counts in the selected area on each subject were determined by 2 independent assessors and the results averaged. The percentage difference in hair count pre and post treatment was calculated and a Paired Sample t-test used to compare means. Only cases where the pre and post treatment hair count areas could be clearly identified on the clinical photographs were analysed.

The efficacy results are provided in Table 2.

	SmoothSkin Gold
Number of Subjects at 6 MonthsPost Treatment	50
Hair Reduction at 6 Months PostTreatment	43.9%
Number of Subjects at 12 MonthsPost Treatment	33
Hair Reduction at 12 Months PostTreatment	36.0%
% of Subjects met success (>30%hair reduction) on all body areas at12 months post-treatment. SubjectSuccess is defined as greater than30% hair reduction at all treatmentsites at 12 months.*	66.7%
* The SmoothSkin Gold clinical study only used single treatment sites onindividual subjects.
Table 2: Clinical Efficacy Results

Substantial Equivalence

The iPulse SmoothSkin Gold Hair Removal System has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the iPulse Smoothskin Gold Hair Removal System and the listed predicate devices do not raise any issues of safety or efficacy. Performance data supports that the device is as safe and as effective as the predicate devices for its intended use. Therefore, the iPulse SmoothSkin Gold Hair Removal System may be found substantially equivalent to its predicate devices.

CONFIDENTIAL

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.