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 Description

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.

AI/ML Overview

The Equinox CO2 Laser System is a medical device, and the provided text describes its 510(k) summary for FDA clearance. The "study" mentioned is a performance test to demonstrate the device's effects on tissue, rather than a clinical trial with acceptance criteria for statistical endpoints.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., "depth must be between X and Y"). Instead, the performance data seems to be presented to demonstrate the effect and healing response of the device, implying that the observed effects were deemed acceptable for its intended use and comparable to a predicate device. The conclusion of "substantial equivalence" is based on these demonstrated effects.

Reported Device Performance:

Parameter Group	Energy	Depth (Day 0)	Width (Day 0)	Depth (Day 3)	Width (Day 3)	Depth (Day 14)	Width (Day 14)
120µm Spot Size	50 mJ	87.4 µm	114.1 µm	59.7 µm	86.8 µm	59.7 µm	86.8 µm
	100 mJ	100.8 µm	195.5 µm	83.6 µm	155.7 µm	-	-
	200 mJ	158 µm	221.5 µm	61.5 µm	179.2 µm	59.1 µm	86.8 µm
800µm Spot Size	50 mJ	50.06 µm	296 µm	36.06 µm	256.01 µm	31.02 µm	170.40 µm
	100 mJ	69.2 µm	360.5 µm	41.03 µm	285.5 µm	25.30 µm	105.01 µm
	200 mJ	81.8 µm	437 µm	66.37 µm	401 µm	20.03 µm	172.04 µm

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The device was used "on a pig." The exact number of pigs or specific treatment sites on the pig is not detailed, but it indicates a very small sample, likely a single animal experimentation.
Data Provenance: The data was generated through an experimental study on a pig. The country of origin is not specified but implicitly within the context of an FDA submission. This is a prospective study in the sense that the experiment was conducted specifically to generate this data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts or their qualifications for evaluating the histology data. It simply states the "targeted area was biopsied to evaluate the effect." It's implied that qualified personnel (e.g., pathologists or histologists) analyzed the biopsies, but no specific details are provided.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. Given the nature of the study (histology on a pig), it's highly unlikely that a formal adjudication process involving multiple human readers for a "test set" in the context of image interpretation was employed. The evaluation was likely direct analysis of tissue samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance data is derived from direct histological analysis of tissue treated by the device, not from human readers interpreting data with or without AI assistance. The concept of "human readers improve with AI vs without AI assistance" does not apply to this type of device and study.

6. Standalone Performance Study

Yes, a form of standalone performance study was done. The "Performance Data: Histology data was submitted to support clearance of the device in fractionated mode" describes the direct effect of the algorithm/device on tissue. This is a direct measurement of the device's physical output (thermal damage zones and healing response) without human-in-the-loop performance measurement.

7. Type of Ground Truth Used

The ground truth used was histology (microscopic examination of biopsied tissue). This provides direct biological evidence of the device's effects (depth and width of thermal damage zones and healing response).

8. Sample Size for the Training Set

The document does not mention a training set. This is because the Equinox CO2 Laser System is a physical laser device, not an AI/machine learning algorithm that requires a training set for model development. The performance evaluation is based on direct physical effects.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this device type, this question is not applicable.

Summary

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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 DriveSuite 160Dallas, TX 75234
Contact Person:	Mr. Tom O'Brien
Telephone:	972-380-2911 - Phone
Email:	tobrien@eclipsemed.com
Preparation Date:	June 17, 2013
Device Trade Name:	Equinox CO2 Laser System
Common Name:	CO2 Laser
Classification Name:	Instrument, Surgical, Powered, laser79-ONG, 21 CFR 878-4810
Legally Marketed Predicate Device:	Equinox CO2 LaserK100487
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.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.

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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.

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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'

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(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number __K131903

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.