IPULSE HAIR REMOVAL SYSTEM

K130315 · Cyden Limited · OHT · Jul 12, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130315
• Device Name: IPULSE HAIR REMOVAL SYSTEM
• Applicant: Cyden Limited
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Jul 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

iPulse Hair Removal System is an intense pulsed light (IPL) device for OTC hair removal. System consists of a base unit housing electrical/electronic sub-assemblies and an applicator containing a Xenon flashlamp, connected via an umbilical cord. Powered by AC via external converter. User applies device to skin (leg, arm, bikini, underarm) to deliver optical radiation. Clinical benefit is reduction of hair density; trial showed 31.3% average hair reduction at 6 months. Device intended for consumer self-use.

Clinical Evidence

Clinical study of 61 subjects; 12 weekly treatments under supervision. Treatment sites: leg, arm, bikini, underarm. Primary endpoint: hair density reduction measured via template-based photography and independent assessment. Results: 31.3% average hair reduction at 6 months. Nonclinical testing included biocompatibility, electrical safety, and software testing.

Technological Characteristics

Intense pulsed light (IPL) system; Xenon flashlamp source; AC powered via external converter; base unit and applicator form factor. Biocompatibility and electrical safety testing performed.

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

• CyDen iPulse Smoothskin M100 series 2 (K122280)
• Shaser IPL Hair Removal System (K103560)
• Flash 'N Go (K082298)

Submission Summary (Full Text)

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# 14130315

## 510(K) SUMMARY

| Submission Date: | July 11th 2013 | JUL 1 2 2013 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter Information | | |
| Company Name:<br>Company Address: | CyDen, Ltd.<br>Technium 2, Kings Road, Swansea, Wales, UK SA1 8PJ | |
| Contact Person: | Dr Mike Kiernan<br>CyDen<br>[phone]<br>[e-mail] | |
| Device Information | | |
| Trade Name: | iPulse 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: | CyDen iPulse Smoothskin M100 series 2: | K122280 |
| | Shaser IPL Hair Removal System<br>Shaser Inc, | K103560 |
| | Flash 'N Go<br>Home Skinovations Inc, | K082298 |
| Device Description: | The iPulse is an intense pulsed light (IPL) system composed of a<br>base unit housing the electrical and electronic sub-assembly and an<br>umbilical cord which is connected to the applicator, located in which<br>is the source of optical radiation, namely a Xenon flashlamp. The<br>system is powered from AC power via an external power converter. | |
| Intended Use: | The iPulse Hair Removal System is an over the counter device<br>intended for the removal of unwanted hair. | |
| Indications for Use: | The iPulse Hair Removal System is indicated for the removal of<br>unwanted hair. | |
| Performance Data: | Nonclinical, clinical and usability testing has been completed for the<br>iPulse Hair Removal System. Nonclinical testing included<br>biocompatibility, electrical safety and software testing. The iPulse<br>Hair Removal System was tested in a clinical study of 61 subjects.<br>Each subject had 12 weekly treatments under clinical supervision.<br>Gel was used with all treatments. Treatment sites included the leg,<br>arm, bikini and underarm. Hair counts were taken in a fixed area<br>located using a template and skin landmarks. The hair count before<br>and after treatment was recorded from photographs and reviewed by<br>independent assessor. The reduction in hair density was | |

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calculated. When used as directed, the clinical trial subjects showed on average 31.3% less hair at 6 months.

Comparison to Predicate Device:

The iPulse 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 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 Hair Removal System may be found substantially equivalent to its predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is oriented towards the upper right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

#### DEPARTMENT OF HEALTH & HUM AN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20093-0002

July 12, 2013

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

Re: K130315

Trade/Device Name: iPulse 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: May 30, 2013 Received: June 05, 2013

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 10 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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Page 2 – Dr. Michael Kiernan

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.

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/deliault:him 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,

### Mark N. Melkerson -S

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

Enclosure

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#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130315

I.T.

iPulse Hair Removal System

Indications for Use:

Device Name:

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (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 Ogden 2013.07.12 07:50:29 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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