FUSION SYSTEM

K093465 · Eclipsemed Global, Inc. · ONF · Jan 5, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093465
• Device Name: FUSION SYSTEM
• Applicant: Eclipsemed Global, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Jan 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 500 – 1200nm intense pulsed light wavelengths are indicated for: - The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) - The treatment of cutaneous lesions, including warts, scars and striae . The 560 – 1200nm intense pulsed light wavelengths are indicated for: - The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations The 600 - 1200nm intense pulsed light wavelengths are indicated for: - The removal of unwanted hair from all skin types and to effect stable, long-term or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The 400 - 1200nm intense pulsed light wavelengths are indicated for: - The treatment of moderate inflammatory acne vulgaris. .

Device Story

Fusion System is an intense pulsed light (IPL) device for dermatological applications. System comprises main console with touch-screen control panel, power supply, cooling system, switching module, isolation transformer, and various handpieces with footswitch. Device emits specific light wavelengths (400-1200nm range) to target melanin, vascular structures, or acne-related targets. Operated by clinicians in a professional setting. Output is controlled light pulses; healthcare provider selects wavelength/parameters based on clinical indication. Benefits include non-invasive treatment of skin lesions, vascular conditions, hair reduction, and acne management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intense Pulsed Light (IPL) system; console-based with touch-screen interface, power supply, cooling system, and interchangeable handpieces. Wavelength ranges: 400-1200nm, 500-1200nm, 560-1200nm, 600-1200nm. Energy source: electrical power supply with isolation transformer. Connectivity: standalone system.

Indications for Use

Indicated for treatment of benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, freckles), cutaneous lesions (warts, scars, striae), benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma, leg veins), hair removal/reduction (skin types I-V), and 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.

Predicate Devices

• Lumenis One Family of Systems (K060448)
• Alma Harmony XL (K072564)

Submission Summary (Full Text)

{0}------------------------------------------------

K093465.

JAN - 5 2010

## Attachment 5 510(K) Summary Fusion System

This 510(K) Summary of safety and effectiveness for the Fusion System is submitted in accordance with the requirements of the SMDA 1990 and following quidance concerning the organization and content of a 510(K) summary.

| Applicant: | Eclipsemed Global, Inc |
|------------|------------------------|
|------------|------------------------|

Address:

(

16850 Dallas Parkway Dallas, TX 75248 972-380-2911 - phone [phone] - fax

972-380-2911 - Phone

[e-mail]

972-380-2953 - Fax

Mr. Igor Gradov

Contact Person:

Telephone: Fax: Email:

Preparation Date: October 31, 2009

Device Trade Name: Fusion System

Common Name:

Classification Name:

Legally Marketed Predicate Device:

Lumenis One Family of Systems K060448

The Fusion System consists of:

Footswitch

Instrument, Surgical, Powered, Iaser

Intense Pulse Light (IPL) System

79-GEX, 21 CFR 878-48,

Alma Harmony XL (for treatment of Acne) K072564

Description of the Fusion System:

> switching module and isolation transformer Variety of handpieces .

.

.

Intended use of the Fusion System:

The 500 - 1200nm intense pulsed light wavelengths are indicated for:

- The treatment of benign pigmented epidermal lesions. . including dyschromia, hyperpigmentation, melasma, ephelides (freckles)
The main console unit that incorporates the touch-screen

control panel, power supply module, cooling system,

- . The treatment of cutaneous lesions, including warts, scars and striae
The 560 - 1200nm intense pulsed light wavelengths are indicated for:

- The treatment of benign cutaneous vascular lesions. . including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea. angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- 1 of 2

{1}------------------------------------------------

Attachment 5 510(K) Summary

## Fusion System

Intended use of the Fusion System:

The 600 - 1200nm intense pulsed light wavelengths are indicated for:

- . The removal of unwanted hair from all skin types and to effect stable, long-term or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The 400 - 1200nm intense pulsed light wavelengths are indicated for:

Performance Data: Results of Clinical Study:

Conclusion:

ે દ

な

The treatment of moderate inflammatory acne vulgaris. . None None

The Fusion system is substantially equivalent to the previously cleared predicate devices that are currently in commercial distribution.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, possibly suggesting care or support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN - 5 2010

Eclipsemed Global, Inc. % Mr. Igor Gradov 16850 Dallas Parkway Dallas, Texas 75248

Re: K093465

Trade/Device Name: Fusion System 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: ONF Dated: December 16, 2009 Received: December 22, 2009

Dear Mr. Gradov:

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

{3}------------------------------------------------

Page 2 - Mr. Igor Gradov

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.

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

{4}------------------------------------------------

## Indications for Use

K093465 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name : Fusion System

Indications for Use:

The 500 – 1200nm intense pulsed light wavelengths are indicated for:

- The treatment of benign pigmented epidermal lesions, including dyschromia, . hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions, including warts, scars and striae .

The 560 – 1200nm intense pulsed light wavelengths are indicated for:

- The treatment of benign cutaneous vascular lesions, including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
The 600 - 1200nm intense pulsed light wavelengths are indicated for:

- The removal of unwanted hair from all skin types and to effect stable, long-term . or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The 400 - 1200nm intense pulsed light wavelengths are indicated for:

- The treatment of moderate inflammatory acne vulgaris. .
Prescription Use xx (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)

Page 1 of 1

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

510(k) Number