EQUINOX CO2 LASER SYSTEM

K100487 · Eclipsemed Global, Inc. · ONG · Nov 29, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100487
• Device Name: EQUINOX CO2 LASER SYSTEM
• Applicant: Eclipsemed Global, Inc.
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Nov 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Equinox CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues. The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.

Device Story

Equinox CO2 Laser System (10,600nm wavelength) delivers thermal energy to epidermis and upper dermis. System comprises main body, color touch screen, arm, hand-piece, and foot switch. In non-fractionated mode, used for soft tissue surgery (incision, excision, ablation, vaporization, coagulation). In fractionated mode, uses scanning optics to deliver patterned thermal energy for skin resurfacing. Operated by clinicians in clinical settings. Output is laser energy; healthcare providers use device to perform surgical or dermatological procedures. Benefits include precise tissue interaction and controlled thermal damage for resurfacing.

Clinical Evidence

Bench testing only. Histology study performed on human arm tissue to evaluate thermal damage zones (depth/width) at energy levels up to 70mJ per microbeam. Measurements recorded at day 0, day 3, and day 14 post-treatment to assess healing response. No clinical study data provided.

Technological Characteristics

10,600nm CO2 laser; scanning optics for fractional delivery; system includes main body, color touch screen, arm, hand-piece, and foot switch. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues (non-fractionated mode) and ablative skin resurfacing (fractionated mode).

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 Affirm CO2 Laser (K081424)

Submission Summary (Full Text)

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Attachment 5 510(K) Summary Equinox CO2 Laser System

Pg 1 of 2

This 510(K) Summary of safety and effectiveness for the Equinox CO2 laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Eclipsemed Global, Inc |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 16850 Dallas Parkway<br>Dallas, TX 75248<br>972-380-2911 - phone<br>972-380-2953 - fax |
| Contact Person: | Mr. Tom O'Brien |
| Telephone: | 972-380-2911 - Phone |
| Fax: | 972-380-2953 - Fax |
| Email: | [e-mail] |
| Preparation Date: | February 15, 2010 |
| Device Trade Name: | Equinox CO2 Laser System |
| Common Name: | CO2 Laser |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-ONG, 21 CFR 878-4810 |
| Legally Marketed Device: | Predicate Cynosure Affirm CO2 Laser<br>K081424 |
| Description of the Equinox CO2 laser | The Equinox CO2 laser has a wavelength of 10,600nm. CO2<br>fractional laser uses scanning optics to deliver a pattern of thermal<br>energy to the epidermis and upper dermis. Device accessories<br>include tip attachments. This system consists of main body, color<br>touch screen, Arm, hand-piece and Foot switch. |
| Intended use of the Equinox CO2 laser | The Equinox CO 2 laser when used in traditional non-fractionated<br>scanner mode is indicated for incision, excision, ablation,<br>vaporization, and coagulation of body soft tissues.<br><br>The Equinox CO 2 laser when used in fractionated mode is<br>indicated for ablative skin resurfacing. |
| Performance Data: | Histology data was submitted to support clearance of the device in<br>fractionated mode. The device was used on a human arm with<br>energy up to 70mJ per microbeam and the target area was<br>biopsied to evaluate the effect. The data was to show the depth<br>and width of thermal damage zones and healing response over<br>time. The following table shows the width and depth of<br>penetration on the day of treatment, day 3 post treatment and day<br>14 post treatment. |

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K100487 pg 2 of 2

## Attachment 5 510(K) Summary Equinox CO2 Laser System

| | 10 mJ | | 40 mJ | | 70 mJ | |
|-----|-----------|-----------|-----------|-----------|-----------|-----------|
| Day | Depth | Width | Depth | Width | Depth | Width |
| 0 | 115.01 µm | 347.30 µm | 200.24 µm | 358.75 µm | 272.56 µm | 362.13 µm |
| 3 | 94.78 µm | 293.71 µm | 164.50 µm | 313.20 µm | 217.22 µm | 334.49 µm |
| 14 | X | X | X | X | 43.87 µm | 95.28 µm |

Results of Clinical Study:

None

Conclusion:

The Equinox CO2 Laser System is substantially equivalent to the Cynosure Affirm CO2 Laser cleared in K081424. The Equinox CO2 Laser System in non-fractionated scanner mode is substantially equivalent in terms of indication for use and technology based on similar technical characteristics. The Equinox CO2 Laser System in fractionated mode is substantially equivalent to the predicate device in terms of indications for use and technology based on similar technology characteristics as well as the provided histology data.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

"NOV 2 9 2010

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

Eclipsemed Global, Inc. % Ms. Connie Hoy 16850 Dallas Parkway Dallas, Texas 75248

Re: K100487

Trade/Device Name: Equinox CO2 Laser 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: ONG, GEX Dated: November 19, 2010 Received: November 22, 2010

Dear Ms. Hoy:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Connie Hoy

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely vours

Sincerely, yours,

Mark A. Millen

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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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

NOV 2 9 2010

Device Name : Equinox CO2 Laser System

The Equinox CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.

The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.

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)

> Concurr e of Device Evaluation (ODE) (Division Sign-Off) Page 1 of 1 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number