(283 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or algorithms that would suggest the use of such technology. The description focuses on the laser's physical properties and intended uses.
Yes
The device is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues, as well as ablative skin resurfacing, all of which are considered therapeutic applications.
No.
The device is described as a CO2 laser used for incision, excision, ablation, vaporization, coagulation, and skin resurfacing, all of which are treatment or surgical procedures rather than diagnostic functions.
No
The device description explicitly lists hardware components such as the main body, color touch screen, arm, hand-piece, and foot switch, indicating it is a physical medical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for surgical procedures (incision, excision, ablation, vaporization, coagulation) and skin resurfacing. These are direct treatments applied to the body.
- Device Description: The description details a laser system used to deliver energy to tissues. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide diagnostic information. IVDs are used to diagnose diseases or conditions.
Therefore, the Equinox CO2 laser, as described, is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
ONG, GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Histology data was submitted to support clearance of the device in fractionated mode. The device was used on a human arm with energy up to 70mJ per microbeam and the target 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. The following table shows the width and depth of penetration on the day of treatment, day 3 post treatment and day 14 post treatment.
Key Metrics
| Day | Depth | Width |
|---|---|---|
| Day 0 (10 mJ) | 115.01 µm | 347.30 µm |
| Day 0 (40 mJ) | 200.24 µm | 358.75 µm |
| Day 0 (70 mJ) | 272.56 µm | 362.13 µm |
| Day 3 (10 mJ) | 94.78 µm | 293.71 µm |
| Day 3 (40 mJ) | 164.50 µm | 313.20 µm |
| Day 3 (70 mJ) | 217.22 µm | 334.49 µm |
| Day 14 (70 mJ) | 43.87 µm | 95.28 µm |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |
| Dallas, TX 75248 | |
| 972-380-2911 - phone | |
| 972-380-2953 - fax | |
| Contact Person: | Mr. Tom O'Brien |
| Telephone: | 972-380-2911 - Phone |
| Fax: | 972-380-2953 - Fax |
| Email: | tobrien@eclipsemed.com |
| Preparation Date: | February 15, 2010 |
| Device Trade Name: | Equinox CO2 Laser System |
| Common Name: | CO2 Laser |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-ONG, 21 CFR 878-4810 | |
| Legally Marketed Device: | Predicate Cynosure Affirm CO2 Laser |
| K081424 | |
| 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 human arm with
energy up to 70mJ per microbeam and the target 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. The following table shows the width and depth of
penetration on the day of treatment, day 3 post treatment and day
14 post treatment. |
1
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
pg 1 of (
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