IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2

K071883 · Cyden Limited · GEX · Jan 23, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K071883
• Device Name: IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2
• Applicant: Cyden Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iPulse System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology and specifically for long term stable, or permanent, hair reduction. In addition, the iPulse System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions. The iPulse System is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.

Device Story

iPulse System (Models I200+, 1300, Quadra Q4 Platinum Series) is a laser surgical instrument used in dermatology, general, and plastic surgery. Device delivers light-based energy to target tissues for hair reduction, vascular lesion treatment, pigmented lesion treatment, and management of inflammatory Acne Vulgaris. Operated by healthcare professionals in clinical settings. Output consists of controlled light pulses; clinical decision-making relies on provider assessment of skin condition and lesion type. Benefits include non-invasive treatment of dermatological conditions and permanent hair reduction.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory classification and intended use.

Technological Characteristics

Laser surgical instrument; energy source is light-based (laser/IPL); intended for dermatological and surgical applications. Specific materials, dimensions, and software details not provided in the summary document.

Indications for Use

Indicated for patients requiring long-term stable or permanent hair reduction, treatment of benign cutaneous vascular lesions, treatment of benign pigmented lesions, and treatment of mild to moderate inflammatory Acne Vulgaris.

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

Public Health Service

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## JAN 23 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cyden Limited % Dr. Michael Kiernan Director Technium 1, Kings Road Swansea, Wales, United Kingdom SAI 8PH

Re: K071883

Trade/Device Name: iPulse System Models 1200+, 1300, Quardra 04 Platinum Series 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: GEX Dated: January 10, 2007 Received: January 14, 2007

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. Iisting 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, 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); 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.

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Page 2 - Dr. Michael Kiernan

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 Compliance 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 Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems 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 address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millican

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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## Indications for Use Statement

510(k) Number (if known): K071883

Device Name: iPulse System Models I200+, 1300, Quadra Q4 Platinum Series

Indications For Use:

The iPulse System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology and specifically for long term stable, or permanent, hair reduction.

In addition, the iPulse System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions.

The iPulse System is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.

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 IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)
Entire Mark Miller

Division of General, Restorative, and Neurchagical Devices

5.3(3) Number KO

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