MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100

K050165 · Cyden Limited · GEX · Apr 19, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050165
• Device Name: MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
• Applicant: Cyden Limited
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 19, 2005
• 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 The IFL Fronessional Oyoten is in thing term stable, or permanent, hair reduction. In addition, the IFL Professional System is indicated for the treatment of benign If addition, the IF Froloolenary of benign pigmented lesions. The IFL Professional is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.

Device Story

IFL Professional System is a pulsed Xenon flashlamp device; delivers energy in 550-1200nm wavelength range. System comprises base unit with electronic control subsystems, umbilical, and handpiece containing light source, filter, and finger switch. Operated by clinicians in dermatological/plastic surgery settings. Device emits light pulses to target skin tissue; intended for hair reduction, pigmented lesion treatment, and acne management. Output parameters are controlled via base unit electronics. Clinical benefit derived from photothermal interaction with target structures.

Clinical Evidence

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

Technological Characteristics

Pulsed Xenon flashlamp; 550-1200nm wavelength range. System includes base unit, umbilical, and handpiece with integrated filter and finger switch. Electronic control subsystems manage energy delivery. Device is a laser surgical instrument (Product Code GEX).

Indications for Use

Indicated for long-term stable or permanent hair reduction, treatment of benign pigmented lesions, and treatment of mild to moderate inflammatory Acne Vulgaris in dermatological and plastic surgery applications.

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, LuxV Handpiece (K040081)
• 5 ro(K) approval nustem with ClearTouch (K032205)
• ICN NLite System (K024189)

Submission Summary (Full Text)

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## APR 1 9 2005

## 7. Summary Statement

KOSO165

### 1. General Information

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

14" January 2005 Summary Preparation Date:

#### 2. Names

IFL Professional System Device Name:

Laser Powered Surgical Instrument Primary Classification Name:

#### 3. Predicate Devices

- Palomar Estelux System, LuxV Handpiece cleared April 2004, . 510(k) approval number K040081;
- 5 ro(K) approval nustem with ClearTouch cleared December 2003, . 510(k) approval number K032205;
- ICN NLite System, cleared June 2003, 510(k) approval number . K024189.

### 4. Product Description

The IFL Professional System is a pulsed Xenon flashlamp delivering energy in The IF L Foressional System to range. The system consists of a base unit the 550 to 1200nm wavelectronic control subsystems, an umbilical containing the election and Should the handpiece, and the handpiece interoonnootion benon light source, filter and finger switch.

#### 5. Indications for Use

The IFL Professional System is indicated for use in Dermatological and Plastic The If L Troicsslonal Byecifically for long term stable, or permanent, hair reduction.

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

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# 6. Rationale for Substantial Equivalence

The IFL Professional system and its predicate devices have the same mode
ly like in the list in the last constant consected. The Indications for Use The IFL Professional system and its produce are no no indications for Use
of action and produce the similar output parameters. The Indical, namely the of action and produce the Similar Odipat purchises are identical, namely the
of the IFL Professional and the prodicate devices are identical, namely the of the IFC Professional and the prodicate .
treatment of mild to moderate inflammatory Acne Vulgaris.

# 7. Safety and Efficacy Information

Not Applicable. Substantial equivalence to the predicate devices is claimed
ial interest in the substant and ristice and intended Indications for Use Not Applicable. Substantial equivaleries to the productions for Use.
due to identical technological characteristics and intended Indications for Use.

### 8. Conclusion

The IFL Professional system has been found to be substantially equivalent to
lled in the submit and subsidiaria technological design and The IFL Professional system has been name to al design and operation and the predicate devices, specifically in testinological interactions. The design and similar in hature to the desired priysionee with the relative international manufacture of the device is in accordanoo with the routent has been minimized.
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 stylized eagle or bird symbol with three curved lines representing its wings or body. The bird is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the bird. The text is in all caps and is smaller than the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 9 2005

Dr. Mike Kiernan Director of Clinical Research CyDen Limited Techium 2, Kings Road Swansea, Wales United Kingdom SA1 8PH

Re: K050165 Trade/Device Name: 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, 2005 Received: January 25, 2005

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, listing 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 oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has matures and regulations administered by other Federal agencies. You must or any I 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Dr. Mike 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 promative nedicate 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 in you attimo 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 other Echermational 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,

Rene R

Miriam C. Provost, Ph.D. Acting 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

K 050162

510(k) Number (if known): ___Not Known

Device Name: IFL Professional

Indications For Use:

The IFL Professional System is indicated for use in Dermatological and Plastic Surgery The IFL Fronessional Oyoten is in thing term stable, or permanent, hair reduction.

In addition, the IFL Professional System is indicated for the treatment of benign If addition, the IF Froloolenary of benign pigmented lesions.

The IFL Professional 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 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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