EQUINOX CO2 LASER

K131903 · Eclipse Aesthetics, LLC · ONG · Sep 19, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131903
• Device Name: EQUINOX CO2 LASER
• Applicant: Eclipse Aesthetics, LLC
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Sep 19, 2013
• Decision: SESE
• Submission Type: Special
• 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 is a 10,600nm wavelength laser device. System components include main body, color touch screen, arm, hand-piece, and foot switch. In non-fractionated mode, device performs incision, excision, ablation, vaporization, and coagulation of soft tissues. In fractionated mode, scanning optics deliver thermal energy patterns to epidermis and upper dermis for skin resurfacing. Operated by clinicians in a clinical setting. Output is controlled laser energy; healthcare providers use device to achieve specific tissue effects based on energy settings and spot sizes. Benefits include precise tissue interaction for surgical and dermatological applications.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and a porcine histological study. Porcine study evaluated thermal damage depth and width using 120um and 800um spot sizes at energy levels up to 200mJ. Results documented thermal damage zones and healing response over 14 days.

Technological Characteristics

10,600nm CO2 laser; scanning optics for fractional delivery; 120um and 800um spot sizes; color touch screen interface; arm and hand-piece delivery system; foot switch activation. Class II device.

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

• Equinox CO2 Laser (K100487)

Submission Summary (Full Text)

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

Attachment 6 510(K) Summary Equinox CO2 Laser System

# K131903

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: | Eclipse Aesthetics, LLC | | | | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| Address: | 13988 Diplomat Drive<br>Suite 160<br>Dallas, TX 75234 | | | | | |
| Contact Person: | Mr. Tom O'Brien | | | | | |
| Telephone: | 972-380-2911 - Phone | | | | | |
| Email: | [e-mail] | | | | | |
| Preparation Date: | June 17, 2013 | | | | | |
| 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 Predicate Device: | Equinox CO2 Laser<br>K100487 | | | | | |
| Description of the Equinox CO2 laser | The Equinox CO2 laser has a wavelength of 10,600nm. CO2 fractional laser uses scanning optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments. This system consists of main body, color 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 scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.<br><br>The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing. | | | | | |
| Performance Data: | Histology data was submitted to support clearance of the device in fractionated mode. The device was used on a pig with energy up to 200mJ per microbeam for both the 120um and the 800um spot sizes. The targeted area was biopsied to evaluate the effect. The data was to show the depth and width of thermal damage zones and healing response over time. | | | | | |

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

## Attachment 6 510(K) Summary Equinox CO2 Laser System

120um Results

| Energy | 50 mJ | | 100 mJ | | 200 mJ | |
|--------|--------|---------|---------|---------|--------|---------|
| Day | Depth | Width | Depth | Width | Depth | Width |
| 0 | 87.4µm | 114.1µm | 100.8µm | 195.5µm | 158µm | 221.5µm |
| 3 | 59.7µm | 86.8µm | 83.6µm | 155.7µm | 61.5µm | 179.2µm |
| 14 | 59.7µm | 86.8µm | - | - | 59.1µm | 86.8µm |

### 800um Results

| Energy | 50 mJ | | 100 mJ | | 200 mJ | |
|--------|----------|----------|----------|-----------|----------|----------|
| Day | Depth | Width | Depth | Width | Depth | Width |
| 0 | 50.06µm | 296µm | 69.2µm | 360.5µm | 81.8µm | 437µm |
| 3 | 36.06 µm | 256.01µm | 41.03 µm | 285.5 µm | 66.37 µm | 401µm |
| 14 | 31.02 µm | 170.40µm | 25.30 µm | 105.01 µm | 20.03 µm | 172.04µm |

Results of Clinical Study:

None

:

Conclusion:

The Equinox CO2 Laser 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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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

September 19, 2013

Eclipse Aesthetics, LLC Mr. Tom O'Brien CEO 13988 Diplomat Drive, Suite 160 Dallas, Texas 75234

Re: K131903

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 Dated: August 18, 2013 Received: August 23, 2013

Dear Mr. O'Brien:

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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

Page 2 - Mr. Tom O'Brien

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

# David Kiaüse -S

for

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

Enclosure

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

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden= 7761
2013.09.18 16:07:08 -04'00'

Page 1 of 1

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number __K131903