IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM

K122280 · Cyden Limited · OHT · Oct 23, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122280
• Device Name: IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
• Applicant: Cyden Limited
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Oct 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The iPulse SmoothSkin Hair Removal System is an intense pulsed light (IPL) device for home-use hair removal. The system consists of a base unit containing electrical/electronic sub-assemblies and an applicator connected via an umbilical cord. The applicator houses a Xenon flashlamp that emits optical radiation. The device is powered by AC via an external converter. Users operate the device by applying the applicator directly to the skin; a removable skin tone sensor is used to assess the treatment site. The device offers three settings with varying pulse durations (single or double pulses) and energy densities (7-10 J/cm2). By delivering light energy to the hair follicle, the device aims to reduce unwanted hair. Clinical evidence demonstrated hair reduction in 83.3% of subjects, with a mean reduction of 54.7% at six months. The device is intended for consumer self-use.

Clinical Evidence

Clinical testing involved 29 subjects who underwent three weekly treatments. Follow-up reviews occurred at four weeks and six months post-treatment. Results showed 83.3% of subjects experienced hair reduction, with a mean hair count reduction of 54.7% at six months. Usability testing was conducted in 47 subjects to evaluate human factors and label comprehension. Nonclinical testing included biocompatibility, electrical safety, and software testing.

Technological Characteristics

Intense pulsed light (IPL) system using a Xenon arc flashlamp. Wavelength range: 530-1100nm. Energy density: 7-10 J/cm2. Spot size: 3cm2. Pulse durations: 25ms (Setting I), 15ms/10ms (Setting II), 10ms/40ms (Setting III). Features a removable optical skin tone sensor. Powered by AC via external converter. Direct tissue illumination via finger switch control.

Indications for Use

Indicated for the removal of unwanted hair in an over-the-counter setting.

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

• Shaser IPL Hair Removal System (K103560)
• Flash 'N Go (K082298)

Submission Summary (Full Text)

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K12 2280 P 1/2

# Traditional 510(k) Premarket Notification iPulse SmoothSkin Hair Removal System

### 3.0 510(K) SUMMARY

| Submission Date: | July 27, 2012 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information | |
| Company Name: | CyDen, Ltd. |
| Company Address: | Technium 2, Kings Road, Swansea, Wales, UK SA1 8PH |
| Contact Person: | William Cotton<br>CyDen<br>[phone]<br>[e-mail] |
| Device Information | |
| Trade Name: | iPulse SmoothSkin Hair Removal System |
| Common Name: | Light based over the counter hair removal system |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and<br>dermatology |
| Device Class: | 21 CFR 878.4810 |
| Predicate Devices: | Shaser IPL Hair Removal System<br>Shaser Inc, K103560<br><br>Flash 'N Go<br>Home Skinovations Inc, K082298 |
| Device Description: | The iPulse SmoothSkin Hair Removal System is an intense pulsed light<br>(IPL) system composed of a base unit housing the electrical and<br>electronic sub-assembly and an umbilical cord which is connected to<br>the applicator, located in which is the source of optical radiation,<br>namely a Xenon flashlamp. The system is powered from AC power via<br>an external power converter. |
| Intended Use: | The iPulse SmoothSkin Hair Removal System is an over the counter<br>device intended for the removal of unwanted hair. |
| Indications for Use: | The iPulse SmoothSkin Hair Removal System is indicated for the<br>removal of unwanted hair. |
| Performance Data: | Nonclinical, clinical and usability testing has been completed on the<br>iPulse SmoothSkin Hair Removal System. Nonclinical testing included<br>biocompatibility, electrical safety and software testing. Clinical<br>testing was conducted in 29 subjects. Each subject underwent three<br>weekly treatments with SmoothSkin, with follow up reviews at four<br>weeks and six months after the last treatment. The majority of study |

CyDen Ltd.
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## Traditional 510(k) Premarket Notification iPulse SmoothSkin Hair Removal System

subjects (83.3%) experienced hair reduction, with a mean hair count reduction of 54.7% at six months. Usability testing was completed in 47 subjects to evaluate device human factors and label comprehension.

The iPulse SmoothSkin Hair Removal System has the same intended Comparison to Predicate Device: use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the iPulse Smoothskin 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 Hair Removal System may be found substantially equivalent to its predicate devices. A technical comparison to the predicates is provided below.

| | PREDICATE DEVICES | | DEVICE |
|---------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Flash N' Go | Shaser IPL | iPulse SmoothSkin Hair Removal<br>System |
| Manufacturer | Home Skinovations Itd | Shaser Inc | CyDen Limited |
| Energy Medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Wavelength Range | 475-1200nm | 650nm - 1100nm | 530 - 1100nm |
| Pulse Duration | 5 milliseconds | 30milliseconds | Setting I:<br>Single pulse 25milliseconds.<br>Setting II:<br>Double pulse 15ms on, 10 ms off.<br>Setting III:<br>Double pulse 10 ms on, 40 ms off. |
| Energy Density | 5J/cm2 | 9J/cm2 | 7-10J/cm2 |
| Spot Size | 6cm2 (3cm by 2 cm) | 2cm2 (1cm by 2cm) | 3cm2 (1.3cm by 2.4 cm) |
| Delivery Device | Direct Illumination To Tissue | Direct Illumination to<br>Tissue | Direct Illumination To Tissue |
| Pulsing Control | Finger Switch | Finger Switch | Finger switch |
| Skin Tone Sensor | Optical Measurement<br>Integral to Handpiece<br>Sensor moveable to<br>treatment site | Optical Measurement<br>Integral to Base Unit<br>Sensor fixed in base unit,<br>treatment site moved to<br>sensor | Optical Measurement<br>Removable from Base Unit<br>Sensor moveable to treatment site |
| Specific Indications<br>for Use | The Flash N'Go is an Over-<br>the-counter device<br>intended for the removal of<br>unwanted hair. | The Shaser IPL is an Over-<br>the-counter device<br>intended for the removal<br>of unwanted hair. | The iPulse SmoothSkin Hair Removal<br>System is indicated for the removal<br>of unwanted hair. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized feathers.

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

Cyden, Limited % Becker and Associates Consulting, Incorporated Mr. Austin Speier Managing Director 2001 Pennsylvania Avenue, Suite 950 Washington, District of Columbia 20006

OCT
23 2012

Re: K122280 Trade/Device Name: iPulse SmoothSkin 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 Dated: July 30, 2012 Received: July 31, 2012

Dear Mr. Speier:

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

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### · Page 2 - Mr. Austin Speier

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Daniel Kraine

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Traditional 510(k) Premarket Notification iPulse SmoothSkin Hair Removal System

CyDen Ltd. Page 6

#### INDICATIONS FOR USE STATEMENT 2.0

510(k) Number (if known):

Device Name:

iPulse SmoothSkin Hair Removal System

Indications for Use:

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

K122280

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

## (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Odenin for mxm

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ision Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122280