IPULSE, MODEL: I150

K083748 · Cyden Limited · GEX · Feb 2, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083748
• Device Name: IPULSE, MODEL: I150
• Applicant: Cyden Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iPulse i150 System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology. The iPulse i150 system emits a wavelength of 530nm to 1200nm and is specifically intended for the long term stable, or permanent, reduction in hair.

Device Story

The IPL iPulse i150 System is an intense pulsed light device used for hair reduction. It emits light in the 530nm to 1200nm wavelength range. The device is intended for use in general and plastic surgery and dermatology settings by trained professionals. It functions by delivering pulses of light to the skin, targeting hair follicles to achieve long-term stable or permanent hair reduction. The healthcare provider operates the system to treat specific skin areas; the output is the light energy delivered to the patient's skin. The device benefits patients by providing a clinical method for hair reduction.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Intense Pulsed Light (IPL) system; wavelength range 530nm to 1200nm; classified under 21 CFR 878.4810 (Laser surgical instrument); product code GEX.

Indications for Use

Indicated for long-term stable or permanent hair reduction in patients seeking cosmetic hair removal.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cyden Limited % Dr. Michael Kiernan Technium, Kings Road The Docks, Swansea, Wales SA1 8PH United Kingdom

Re: K083748

Trade/Device Name: IPL iPulse i150 System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 22, 2009

- 2 2009

Dear Dr. Kiernan:

Received: January 26, 2009

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, insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, TDA max 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 manion over not 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); good manufacturing practice requirements as set

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Page 2 - Dr. Michael Kiernan

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Crampliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pestmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Syrcems at [phone]. 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 adHress. http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulkerson

- Mark N. Melkerson Director Division of General, Restorative and Neurological 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): K083748

Device Name: IPL iPulse i150 System

Indications For Use:

The iPulse i150 System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology.

The iPulse i150 system emits a wavelength of 530nm to 1200nm and is specifically intended for the long term stable, or permanent, reduction in hair.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Ove r-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

> Concurrence of CDRH, Office of Device Ex off Off

> > Division of General, Restorative, and Neurological Devices

510 (k) Number 1-of