(86 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the physical properties and function of a CO2 laser.
Yes
The device is used for medical procedures such as incision, excision, ablation, vaporization, coagulation of soft tissues, and ablative skin resurfacing, which are therapeutic interventions.
No
Explanation: The device description and intended use focus on treatment (incision, excision, ablation, vaporization, coagulation, and skin resurfacing), not on diagnosing diseases or conditions. The histology data confirms its use for evaluating tissue effects rather than diagnostic capabilities.
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, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Equinox CO2 Laser Function: The description clearly states the Equinox CO2 laser is used for "incision, excision, ablation, vaporization, and coagulation of body soft tissues" and "ablative skin resurfacing." These are procedures performed directly on the patient's body, not on specimens taken from the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is to deliver energy to tissue.
Therefore, based on the provided information, the Equinox CO2 laser is a therapeutic device used for surgical and dermatological procedures, 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
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
120um Results:
Energy 50 mJ: Day 0 (Depth: 87.4µm, Width: 114.1µm); Day 3 (Depth: 59.7µm, Width: 86.8µm); Day 14 (Depth: 59.7µm, Width: 86.8µm)
Energy 100 mJ: Day 0 (Depth: 100.8µm, Width: 195.5µm); Day 3 (Depth: 83.6µm, Width: 155.7µm); Day 14 (-)
Energy 200 mJ: Day 0 (Depth: 158µm, Width: 221.5µm); Day 3 (Depth: 61.5µm, Width: 179.2µm); Day 14 (Depth: 59.1µm, Width: 86.8µm)
800um Results:
Energy 50 mJ: Day 0 (Depth: 50.06µm, Width: 296µm); Day 3 (Depth: 36.06 µm, Width: 256.01µm); Day 14 (Depth: 31.02 µm, Width: 170.40µm)
Energy 100 mJ: Day 0 (Depth: 69.2µm, Width: 360.5µm); Day 3 (Depth: 41.03 µm, Width: 285.5 µm); Day 14 (Depth: 25.30 µm, Width: 105.01 µm)
Energy 200 mJ: Day 0 (Depth: 81.8µm, Width: 437µm); Day 3 (Depth: 66.37 µm, Width: 401µm); Day 14 (Depth: 20.03 µm, Width: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 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 | |||||
| Suite 160 | ||||||
| Dallas, 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, laser | |||||
| 79-ONG, 21 CFR 878-4810 | ||||||
| Legally Marketed Predicate Device: | Equinox CO2 Laser | |||||
| 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. |
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 (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
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