IFL PROFESSIONAL SYSTEM, MODEL C100

K040156 · Cyden Limited · GEX · Mar 24, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040156
• Device Name: IFL PROFESSIONAL SYSTEM, MODEL C100
• Applicant: Cyden Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IFL Professional System is indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction. In addition, the IFL Professional System is indicated for the treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations: and the treatment of benign pigmented lesions.

Device Story

IFL Professional System is a pulsed Xenon flashlamp device; delivers energy in 530-1200nm range. System comprises base unit with electrical/electronic control subsystems, umbilical cable, and handpiece containing light source, filter, and finger switch. Operated by clinicians in dermatological/plastic surgery settings. Device transforms electrical energy into pulsed light output; light targets specific skin structures for hair reduction and lesion treatment. Output allows clinicians to perform dermatological procedures; benefits include permanent hair reduction and clearance of benign vascular/pigmented lesions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and intended indications for use compared to predicate devices.

Technological Characteristics

Pulsed Xenon flashlamp; 530-1200nm wavelength range; electrical excitation; base unit with handpiece and finger switch; design and manufacture in accordance with international standards.

Indications for Use

Indicated for dermatological and plastic surgery patients requiring long-term stable or permanent hair reduction, treatment of benign cutaneous vascular lesions (e.g., port wine stains, hemangiomas, telangiectasias, rosacea, melasma, angiomas, poikiloderma of Civatte, leg veins, venous malformations), and treatment of benign pigmented lesions.

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

• Palomar Estelux System (K020453)
• Lumenis Vasculite System (K030342)

Submission Summary (Full Text)

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K040156 1 of 2

510(k) Submission IFL Professional System MAR 2 4 2004

## Section 12 510(k) Summary Statement Cyden Limited IFL Professional System

#### 1. General Information

- Submitter: Cyden Ltd Technium Kings Road, The Docks Swansea, Wales, UK, SA1 8PH
Dr Mike Kiernan - Technical Director Contact Person:

14th January 2004 Summary Preparation Date:

#### 2. Names

IFL Professional System Device Name:

Laser Powered Surgical Instrument Primary Classification Name:

#### 3. Predicate Devices

- Palomar Estelux System, cleared May 2002, 510(k) approval . number K020453:
- Lumenis Vasculite System, cleared July 2003, 510(k) approval . number K030342.

## 4. Product Description

The IFL Professional System is a pulsed Xenon flashlamp delivering energy in the 530 to 1200nm wavelength range. The system consists of a base unit containing the electrical and electronic control subsystems, an umbilical interconnection between the base unit and the handpiece, and the handpiece which houses the xenon light source, filter and finger switch.

## 5. Indications for Use

The IFL Professional System is indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction.

In addition, the IFL Professional System is indicated for the treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations: and the treatment of benign pigmented lesions.

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K040156 2 of 2

510(k) Submission IFL Professional System

## 6. Rationale for Substantial Equivalence

The IFL Professional system and its predicate devices have as a come technological characteristics, i.e. pulsed light output in the 530-1200nm wavelength range produced via electrical excitation of xenon flashlamps. The wavolonger for Use of the IFL Professional and the predicate devices are identical, namely long term stable, or permanent, hair reduction and the treatment of benign pigmented and vascular lesions.

## 7. Safety and Efficacy Information

Not Applicable. Substantial equivalence to the predicate devices is claimed rtor identical technological characteristics and intended Indications for Use.

#### 8. Conclusion

The IFL Professional system has been found to be substantially equivalent to the predicate devices, specifically in technological design and operation and similar in nature to the desired physiological interactions. The design and manufacture of the device is in accordance with the relative international standards and the potential risk to operator and patient has been minimized.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized eagle emblem with three parallel lines forming the body and wings.

MAR 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Dr. Michael N. Kiernan Technical Director Cyden Limited Technium Kings Road, The Docks Swansea Wales, UK, SA1 8PH

Re: K040156

Trade/Device Name: IFL Professional 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 14, 2004 Received: January 23, 2004

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

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 cquivalence 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 N. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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

510(k) Number (if known): K040156

Device Name: IFL Professional System

Indications For Use:

The IFL Professional System is indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction.

In addition, the IFL Professional System is indicated for the treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; and the treatment of benign pigmented lesions.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_Ko40156