(253 days)
Not Found
No
The summary describes a traditional CO2 laser device and its intended uses. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The performance study is a histological study on pigs, not a study evaluating the performance of an AI/ML algorithm.
Yes
The device is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues and for ablative skin resurfacing, which are therapeutic interventions.
No
The device is described as a CO2 laser used for incision, excision, ablation, vaporization, and coagulation of body soft tissues, as well as ablative skin resurfacing. These are therapeutic and surgical functions, not diagnostic ones.
No
The device description clearly outlines hardware components such as a main body, color touch screen, arm, hand-piece, and foot switch, indicating it is a physical laser system, 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, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a CO2 laser used for surgical procedures on the body (incision, excision, ablation, vaporization, coagulation of soft tissues, and skin resurfacing). It directly interacts with the patient's body, not with specimens taken from the body.
- Intended Use: The intended use is for surgical and dermatological procedures, not for analyzing biological samples.
Therefore, based on the provided information, the Edge CO2 laser is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Edge 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 Edge CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
Product codes
ONG
Device Description
The Edge 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, epidermis and upper dermis
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A study was conducted to show the depth of penetration for each microdot using histology on pigs.
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
510(K) Summary Edge CO2 Laser System
NOV 1 Ó 2010
This 510(K) Summary of safety and effectiveness for the Edge 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: | JM System Co., LTD | FDA CDRH DMC |
|---|---|---|
| Address: | 410, Daerung Techno Town 8th | |
| 481-1, Gasan-dong | ||
| Geumcheon-gu | ||
| Seoul, Korea 153-775 | SEP 30 2010 | |
| Contact Person: | Mr. Su-Gun Lee | Received K31 |
| Telephone: | ||
| Fax: | ||
| Email: | 82(02)2163-0158 - phone | |
| +82(02)2163-8932 – fax | ||
| didvkd@gmail.com | ||
| Preparation Date: | February 15, 2010 | |
| Device Trade Name: | Edge CO2 Laser System | |
| Common Name: | CO2 Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser | |
| 79-ONG, 21 CFR 878-4810 | ||
| Legally Marketed Predicate | ||
| Device: | Cynosure Affirm CO2 Laser | |
| K081424 | ||
| Description of the Edge CO2 | ||
| laser | The Edge 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 Edge CO2 | ||
| laser | The Edge 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 Edge CO 2 laser when used in fractionated mode is indicated | ||
| for ablative skin resurfacing. | ||
| Performance Data: | A study was conducted to show the depth of penetration for each | |
| microdot using histology on pigs. | ||
| Results of Clinical Study: | None | |
| Conclusion: | The Edge CO2 Laser System is substantially equivalent to the | |
| previously cleared predicate devices that are currently in | commercial distribution |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JM System Co., Ltd. % Mr. Su-Gun Lee 410, Daerung Techno Town 8th 481-1, Gasan-dong Geumcheon-gu Seoul, Korea 153-775
NOV 1 0 2010
Re: K100590
Trade/Device Name: Edge 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: October 18, 2010 Received: November 09, 2010
Dear Mr. Lee:
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.
2
Page 2 - Mr. Su-Gun Lee
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 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.
Fiz Dohnson N.N.
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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Page 1 of (1)
Indications for Use
NOV 1 0 2010
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name : Edge CO2 Laser System
The Edge 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 Edge 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)
Nulke Syle for mrm
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K100590