(182 days)
Not Found
No
The description focuses on the laser technology, hardware components, and user interface (LCD touchscreen and proprietary SW) for controlling system parameters. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies. The performance studies describe the physical effects of the laser on tissue, not the performance of any AI/ML algorithm.
Yes
The device is used for dermatological procedures requiring ablation, coagulation, and resurfacing of soft tissue, which are therapeutic interventions.
No
The device is described as a fractional CO2 laser intended for dermatological procedures requiring ablation, coagulation, and resurfacing of soft tissue, which are treatment-oriented functions, not diagnostic ones.
No
The device description explicitly states it is a "Fractional CO2 laser device" and details hardware components like a laser module, power supply, scanner, electrical components, and an articulated arm with lenses. While it mentions proprietary software controlling parameters, the core of the device is hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin." This describes a therapeutic or surgical procedure performed directly on the patient's body.
- Device Description: The device is a "Fractional CO2 laser device" that transmits laser energy to tissue. This is a physical intervention on the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
The device is clearly intended for direct treatment of the patient's skin, not for analyzing samples taken from the patient.
N/A
Intended Use / Indications for Use
Dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
Product codes
GEX
Device Description
The eMatrix CO2 is a Fractional CO2 laser device intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue including skin. The device console houses the major units of the system that include the laser module, the power supply, the scanner and all other electrical components. Laser is transmitted to the tissue via a series of lens integrated into the articulated arm. The system parameters are controlled via a LCD touchscreen and proprietary SW.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, including 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Evaluation of skin biopsies revealed morphological changes, which validation: were created under the impact of the eMatrix CO2 of skin resurfacing, as expressed via demarcated zones of ablation and coagulation. The different treatment modes led to a different impact in depth and width of the tissue. The affected zones tended to become deeper as the level of energy employed was increased .The affected zone were of uniform fractional phenotype, leaving intact, non-affected tissue between treated spots.
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
Image /page/0/Picture/1 description: The image shows the word "Syneron" in a stylized font. Below the word "Syneron" is the phrase "Superior Technology, Ultimate Customer Care" in a smaller font. The text appears to be slightly pixelated, suggesting it may be a scan or a low-resolution image. The overall impression is that of a company logo or brand name with a tagline.
NOV - 9 2010
510(K) Summary of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
| Applicant name: | Syneron Medical Ltd.,
Industrial Park, P.O.B. 550
Yokneam Illit, 20692, Israel |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Avi Hirshnzon
VP of QA and Regulatory Affairs
Tel : + 972 54 330 3402, + 972 732 442 200, Ext. 254
Fax : + 972 732 442 202
E-mail : avih@syneron.com |
| Trade Name: | eMatrix CO2 |
| Common name: | CO2 laser system |
| Classification: | Name: powered laser surgical instrument
Product Code: GEX
Regulation No: 878.4810
Class: II
Classification Panel: General & Plastic Surgery |
| Predicate Devices: | Substantial equivalence to the following predicate devices is
claimed:
- Fraxel III SR Laser System (Fraxel re:pair™) and accessories
K071051; Reliant Technologies. - Alma Lasers Family of THERMO-XEL Handpieces Pixel Models:
2940, 1060 K072182; Alma Lasers - Alma Lasers THERMO-XEL CO2 Laser System and Delivery
Device Accessories K080463; Alma Lasers |
1
Image /page/1/Picture/0 description: The image shows the word "Symeron" in a stylized font. Below the word "Symeron" is the phrase "Superior Technology Ultimate Customer Care" in a smaller font. The text is black and the background is white. The image appears to be a logo or brand name.
Device description:
The eMatrix CO2 is a Fractional CO2 laser device intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue including skin. The device console houses the major units of the system that include the laser module, the power supply, the scanner and all other electrical components. Laser is transmitted to the tissue via a series of lens integrated into the articulated arm. The system parameters are controlled via a LCD touchscreen and proprietary SW.
Indication for Use Dermatological procedures requiring ablation, coagulation and Statement: resurfacing of soft tissue, including skin.
Performance Evaluation of skin biopsies revealed morphological changes, which validation: were created under the impact of the eMatrix CO2 of skin resurfacing, as expressed via demarcated zones of ablation and coagulation. The different treatment modes led to a different impact in depth and width of the tissue. The affected zones tended to become deeper as the level of energy employed was increased .The affected zone were of uniform fractional phenotype, leaving intact, non-affected tissue between treated spots.
Conclusion: . We have demonstrated that the eMatrix CO2 meets its labeled performance claims, and that it is substantially equivalent to the predicate devices
05/09/2010
Date
Avi Hirshzon
VP QA & Regulatory Affairs
Syneron Medical Ltd.
5-2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Syneron Medical Ltd. % Mr. Avi Hirshnzon VP Quality Assurance and Regulatory Industrial Zone, Tavor Building Yokneam Illit 20692 P.O. Box 550, Israel
Re: K101321
Trade/Device Name: eMatrix CO2 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: GEX Dated: November 04, 2010 Received: November 05, 2010
Dear Mr. Hirshnzon:
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 linbility 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.
NOV - 9 2010
3
Page 2 - Mr. Avi Hirshnzon
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 (OS) 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.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
NOV - 9 2010
510(k) Number: K101321
Device Name: eMatrix CO2
Indications for Use:
Dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
Over-The-Counter Use Prescription Use _ ______________________________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence o Office of Device Evaluation (ODE)
Sign-Off) (Division Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K101321