iPulse Smooth Skin Gold Hair Removal System

K143003 · Ipulse Limited · OHT · Jun 18, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K143003
• Device Name: iPulse Smooth Skin Gold Hair Removal System
• Applicant: Ipulse Limited
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Jun 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

iPulse SmoothSkin Gold is an intense pulsed light (IPL) system for over-the-counter hair removal. Device consists of a handset (capacitor, charger, control electronics, optics, lamp, filter, reflector, light pipe, trigger, and skin tone/proximity sensors) and an external power supply. User operates device by placing handset on skin; optical sensors measure skin tone to determine appropriate energy output. Device delivers xenon arc flashlamp pulses to tissue to target hair follicles. Output settings are adjusted based on measured skin tone. Clinical efficacy is determined by hair count reduction at 6 and 12 months. Benefits include long-term hair regrowth reduction. Device is intended for home use by consumers.

Clinical Evidence

Prospective clinical study of 50 subjects receiving 12 weekly treatments. Primary endpoint: hair reduction at 6 and 12 months post-treatment. Results: 43.9% hair reduction at 6 months (n=50) and 36.0% at 12 months (n=33). 66.7% of subjects achieved >30% hair reduction at 12 months. Analysis used paired sample t-tests on averaged independent assessor counts.

Technological Characteristics

IPL system using xenon arc flashlamp. Wavelength range: 510-1100nm. Pulse duration: 2-10ms. Energy density: 3-6J/cm². Spot size: 3cm². Features integrated optical skin tone sensor for continuous measurement. Powered by external 24V DC supply (110V/230V AC input). Handset includes capacitor, control electronics, and optical assembly.

Indications for Use

Indicated for removal of unwanted hair and permanent reduction in hair regrowth in adults. Permanent reduction defined as long-term, stable reduction in hair count at 6, 9, and 12 months post-treatment regimen.

Regulatory Classification

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.

Predicate Devices

• iPulse Smoothskin Hair Removal System (K130315)
• Shaser HRS2 IPL Hair Removal System (K120080)
• mē (K131649)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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#### 3.0 510(K) SUMMARY

| Submission Date: | 15th October 2014 | | | PREDICATE DEVICES | | | DEVICE |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------------|
| Submitter Information | | | Device Name | iPulse Hair Removal<br>System | Shaser HRS2 IPL | mē | iPulse Smooth Skin<br>Gold |
| Company Name:<br>Company Address: | iPulse Limited.<br>Technium 2, Kings Road, Swansea, Wales, UK SA1 8PJ | | K Number | K130315 | K120080 | K131649 | K143003 |
| Contact Person: | Dr Mike Kiernan<br>UK [phone]<br>[e-mail] | | 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 | | Wavelength<br>Range | 530-1100nm | 650-1100nm* | 550-1200nm | 510-1100nm |
| Common Name: | Light based over the counter hair removal system | | Pulse Duration | Variable -<br>Single pulse<br>25milliseconds.<br>to<br>Double Pulse 20ms<br>on, 60 ms off. | 30 milliseconds | ~5ms | 2ms to 10ms |
| Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery 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 2.4<br>cm) | 2cm² (1cm by 2cm) | 3.3cm2 (3.3cm by<br>1.0cm) | 3cm² |
| Predicate Devices: | iPulse Smoothskin Hair Removal System<br>K130315<br>CyDen Limited | | Delivery Device | Direct Illumination<br>To Tissue | Direct Illumination to<br>Tissue | Direct Illumination to<br>Tissue | Direct Illumination to<br>Tissue |
| | The Shaser HRS2 IPL Hair Removal System<br>K120080<br>ShaserInc | | Pulsing Control | Finger switch | Finger switch | Finger Switch | Finger switch |
| | mē<br>K131649<br>Syneron Beauty Ltd | | Skin Tone Sensor | Optical<br>Measurement<br>Removable from<br>Base Unit.<br><br>Sensor moveable to<br>treatment site | Optical<br>Measurement<br>Integral to Base Unit<br><br>Sensor fixed in base<br>unit, treatment site<br>moved to sensor | Electrical Contact | Optical<br>Measurement<br>Integral to device.<br><br>Continuous<br>measurement. |
| Specific<br>Indications for<br>Use | The iPulse Hair<br>Removal System is<br>an Over-the-counter<br>device intended for<br>the removal of<br>unwanted hair. | The Shaser HRS2 is<br>an Over-the-counter<br>device intended for<br>the removal of<br>unwanted hair. It is<br>also intended for<br>permanent reduction<br>in unwanted hair.<br>Permanent hair<br>reduction is defined<br>as the long-term<br>stable reduction in<br>the numbers of hairs<br>regrowing when<br>measured at 6,9 and<br>12 months after the<br>completion of a<br>treatment regimen. | The me is an over-<br>the-counter device<br>indicated for the<br>removal of unwanted<br>hair. Me is also<br>intended for<br>permanent in hair<br>growth following an<br>initial treatment<br>regimen with or<br>without maintenance<br>when measured at<br>6,9 and 12 months. | The iPulse<br>SmoothSkin Gold<br>Hair Removal System<br>is indicated for the<br>removal of unwanted<br>hair. The iPulse<br>Smoothskin Gold is<br>also indicated for the<br>permanent reduction<br>in hair regrowth,<br>defined as the long-<br>term, stable<br>reduction in the<br>number of hairs<br>regrowing when<br>measured at 6, 9 and<br>12 months after the<br>completion of a<br>treatment 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:

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.

# 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

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.

# 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 Months<br>Post Treatment | 50 |
| Hair Reduction at 6 Months Post<br>Treatment | 43.9% |
| Number of Subjects at 12 Months<br>Post Treatment | 33 |
| Hair Reduction at 12 Months Post<br>Treatment | 36.0% |
| % of Subjects met success (>30%<br>hair reduction) on all body areas at<br>12 months post-treatment. Subject<br>Success is defined as greater than<br>30% hair reduction at all treatment<br>sites at 12 months.* | 66.7% |
| * The SmoothSkin Gold clinical study only used single treatment sites on<br>individual subjects. | |
| <b>Table 2: Clinical Efficacy Results</b> | |

# 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