MINISILK FT

K082040 · El.En Electronic Engineering Spa · ONF · Aug 27, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082040
• Device Name: MINISILK FT
• Applicant: El.En Electronic Engineering Spa
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Aug 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Minisilk FT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.

Device Story

Minisilk_FT is a powered, non-laser surgical instrument utilizing intense pulsed light (IPL) for dermatological applications. Device consists of a console and handpieces containing a Xenon flashlamp. System emits light in the 500-1200 nm wavelength range. Operation is activated via footswitch. Used in clinical settings by trained professionals to deliver thermal energy to target tissues. Clinical effect achieved through photothermolysis and photocoagulation. System weighs 16 kg with dimensions 22x37x45 cm; requires 115 VAC power. Output is controlled by the operator to treat vascular and pigmented lesions or reduce hair. Benefits include non-invasive treatment of specified skin conditions.

Clinical Evidence

No clinical performance data provided. Substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Powered light-based non-laser surgical instrument. Emits intense pulsed light via Xenon flashlamp. Wavelength range: 500-1200 nm. Electrical requirements: 115 VAC, 10A, 50-60 Hz. Form factor: 16 kg, 22x37x45 cm console. Activation: Footswitch. No software algorithm or connectivity specified.

Indications for Use

Indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, and treatment of benign pigmented lesions in patients requiring dermatological light-based therapy.

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

• Cynosure Photolight PL (K031258)

Submission Summary (Full Text)

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510(K) Summary

El.En. S.p.A.
via Baldanzese, 17
50041 Calenzano (FI), Italy
Phone: [phone] Fax: [phone]
Email: [e-mail]

Andrea Tozzi
Quality System Manager & Official Correspondent
via Baldanzese, 17
50041 Calenzano (FI), Italy
Phone: [phone] Fax: [phone]
Email: [e-mail]

August 26th, 2009

Minisilk_FT

Intense Pulsed Light System

Powered light based non-laser surgical instrument with thermal effect
ONF
21 CFR 878.4810

Cynosure Photolight PL - K031258

The Minisilk_FT is a pulsed light system having a Xenon flashlamp

K082040

pg 1 of 1

AUG 2 7 2009

located in the handpieces. It is a light source emitting in the wavelength

Emission activation is by footswitch. Overall weight of the system is 16

Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.

The Minisilk FT pulsed light device is indicated for permanent hair

reduction, photocoagulation of vascular lesions, photothermolysis of

The Minisilk FT is another safe and effective device for permanent hair

reduction, photocoagulation of vascular lesions, photothermolysis of

blood vessels and treatment of benign pigmented lesions.

blood vessels and treatment of benign pigmented lesions.

Device Description:

Equivalent Devices:

Date Summary Prepared:

Device Trade Name:

Classification Name:

Common Name:

Submitter:

Contact:

Indications for Use:

Comparison:

The Minisilk FT system has the same indications for use, the same principle of operation, and essentially the same wavelength range and pulse energy range as the predicate device.

kg, and the size is 22x37x45 cm (H x W x D).

range 500-1200 nm.

Nonclinical Performance Data: None Clinical Performance Data: None

Conclusion:

Additional Information:

None

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Image /page/1/Picture/13 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, suggesting themes of protection and national identity.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

El. En. S.p.A. % Ms. Andrea Tozzi Quality System Manager & Official Correspondent Viaa Baldanzese, 17 50041 Calenzano (FI) - Italy

AUG 2 7 2009

Re: K082040

Trade/Device Name: Minisilk FT 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: ONF

Dated: August 5, 2009 Received: August 10, 2009

Dear Mr. Tozzi:

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 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 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 - Ms. Andrea Tozzi

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/default.htm 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
Director

Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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pg 1 of

510(K) Number (if known): K082040

Device Name: ____ Minisilk_FT____

Indications For Use:

The Minisilk FT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.

Prescriptive Use (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mial R. Ogle forman

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

(Optional Format 1-2-96)