EPI-C PLUS

K070494 · Espansione Marketing S.P.A · GEX · May 1, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070494
• Device Name: EPI-C PLUS
• Applicant: Espansione Marketing S.P.A
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is intended for dermatological use by physicians and healthcare professionals for the following: - Removal of unwanted hair in all skin types (from 570 to 1200nm filters) - Treatment of vascular and benign pigmented lesions, cutaneous lesions including warts, scars, striae and facial and leg veins (from 550 to 1200mm filter) - Treatment of Acne (from 390 to 1200nm filter) .

Device Story

EPI-C PLUS is a high-intensity pulsed light (IPL) system for dermatological applications. Device consists of a principal unit (power supply, control board, TFT display, capacitors), a handpiece, and a removable lamp/filter group. Operation involves discharging capacitors through a xenon flash lamp to emit light in the 390-1200nm range. Specific filters (390-1200nm, 550-1200nm, 570-1200nm) are used to select wavelengths for specific indications. Operated by physicians or healthcare professionals in a clinical setting. Output is pulsed light applied to patient skin; provider uses device to treat lesions, remove hair, or manage acne. Benefits include non-invasive treatment of various dermatological conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pulsed light system; xenon flash lamp; wavelength range 390-1200nm; removable filter groups; power supply with AC/DC converter; microcontroller-based control system; TFT display interface; handpiece with removable cable.

Indications for Use

Indicated for dermatological use by physicians/healthcare professionals for hair removal (all skin types), treatment of vascular/benign pigmented lesions, cutaneous lesions (warts, scars, striae, facial/leg veins), and acne.

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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EPI-C PLUS

CONFIDENTIAL

MAY - 1 2007

K070494

# SECTION 4: EXECUTIVE SUMMARY

## Device Description

The device is designed and manufactured to emit a high intensity pulsed light applied to the patient's skin. The light is emitted by a quick discharge of capacitors on a xenon flash lamp with a high energy. The lamp delivers a wavelength in the band of 390-1200nm.

The three principal parts of this system are:

- The Principal Unit which contain all circuitry to control the device. This unit 】. is composed of:
- . Power Supply section which allows the necessary power supply to the system (power supply socket, main switch, power supply transformer, and the Ac/Dc the power supply converter, for PC board).
- Control section is composed of control board PC board and human . interface system (TFT display )
- Power section allows generating and storing the energy used to generate . the output light. It is composed of power board and power capacitors.
- 2. The Handpiece contains circuitry to control the Lamp & Filter group. It is connectod with the principal unit with a removable cable
- 3. The Lamp & Filter group is a removable box that contains Xenon Flash Lamp and Filter mounted on to the handpiece.

## Intended Use

This product is intended for dermatological use by physicians and healthcare professionals for the following:

- Removal of unwanted hair in all skin types (from 570 to 1200nm filters) �
- Treatment of vascular and benign pigmented lesions, cutaneous lesions including � warts, scars, striae and facial and leg veins (from 550 to 1200mm filter)
- Treatment of Acne (from 390 to 1200nm filter) .

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## EPI-C PLUS

#### Device Description

The device is designed and manufactured to emit a high intensity pulsed light applied to the patient's skin. The light is emitted by a quick discharge of some capacitors on a xenon flash lamp with a high energy. The lamp delivers a wavelength in the band of 390-1200nm. The three principal parts of the system include:

- The Principal Unit, that contain all circuitry to control the device as the ♥ capacitor charge system, the microcontroller and all the electronic parts; the
- The Handpiece, that contain part of circuitry to control the Lamp & Filter キ group;
- The Lamp & Filter group, a removable box that contain Xenon Flash Lamp . and Filter mounted on to the handpiece.

#### Intended Use

This product is intended for dermatological use by physicians and healthcare professionals for the following:

- Removal of unwanted hair in all skin types (from 570 to 1200nm filter) .
- Treatment of vascular and benign pigmented lesions, cutaneous lesions including . warts, scars, strine and facial and leg veins (from 550 to 1200nm filter).
- Treatment of Acne (from 390 to 1200nm filter) .

# Comparison to Predicate Devices

The intended use and the technological characteristics of the Espansione Marketing EPI-C PLUS and its predicate devices are very similar as explained in section 6 of this submission. Espansione Marketing EPI-C PLUS is substantially equivalent to its predicate device cited above, and raises no new safety and/or efficacy issues.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tails, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Espansione Marketing SPA % Isenet Guido Bonapace Via Emilia, 418 40068 – San Lazzaro di Savena Bologna, Italy

MAY - 1 2007

Re: K070494 Trade/Device Name: EPI-C PLUS 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: February 15, 2007 Received: February 20, 2007

Dear Guido Bonapace:

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 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

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Page 2 – Guido Bonapace

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 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

510(k) Number : K070494

Device Name: EPI-C PLUS

## Indications for Use:

This product is intended for dermatological use by physicians and healthcare professionals for the following:

- Removal of unwanted hair in all skin types (from 570- to 1200mm filter) .
- Treatment of vascular and benign pigmented lesions, cutaneous lessons including . warts, scars, striae and facial and leg veins (from 550 to 1200mm filter).
- Treatment of Acne (from 390 to 1200nm filter) .

AND/OR Over-the-Counter Use Prescription Use _ X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

** CERTIFICATION IS TO BE ON COMPANY LETTERHEAD, SIGNED AND DATED BY THE RESPONSIBLE INDIVIDUAL ** ]

(Division Sign-Off)
Division of General, Restorative,
Division of General, Restorative,
Espansione, Mark and Neurological Devices
EPI-C PLUS
510(k) Number LG74949

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CONFIDENTIAL