EMATRIX CO2

K101321 · Syneron Medical, Ltd. · GEX · Nov 9, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101321
• Device Name: EMATRIX CO2
• Applicant: Syneron Medical, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

Device Story

eMatrix CO2 is a fractional CO2 laser system for dermatological ablation, coagulation, and skin resurfacing. System comprises a console housing laser module, power supply, and scanner; laser energy is delivered to tissue via an articulated arm with integrated lenses. Operated by clinicians in a medical setting, the system is controlled via an LCD touchscreen and proprietary software. The device creates a fractional phenotype by delivering energy in a pattern that leaves intact, non-affected tissue between treated spots. By adjusting energy levels, the clinician modulates the depth and width of ablation and coagulation zones, allowing for targeted tissue modification. This fractional approach facilitates skin resurfacing while maintaining islands of healthy tissue to promote healing.

Clinical Evidence

Bench testing only. Performance validation involved evaluation of skin biopsies following treatment with the eMatrix CO2. Results demonstrated morphological changes consistent with fractional resurfacing, specifically demarcated zones of ablation and coagulation. The study confirmed that energy level adjustments correlate with the depth and width of affected tissue zones, maintaining a uniform fractional phenotype with intact tissue between treated spots.

Technological Characteristics

Fractional CO2 laser system. Components include laser module, power supply, scanner, and articulated arm with integrated lens delivery. System is controlled via LCD touchscreen and proprietary software. Operates as a powered laser surgical instrument (Class II, GEX).

Indications for Use

Indicated for dermatological procedures requiring ablation, coagulation, and resurfacing of soft tissue, including skin.

Regulatory Classification

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.

Predicate Devices

• Fraxel III SR Laser System (Fraxel re:pair™) and accessories (K071051)
• Alma Lasers Family of THERMO-XEL Handpieces Pixel Models: 2940, 1060 (K072182)
• Alma Lasers THERMO-XEL CO2 Laser System and Delivery Device Accessories (K080463)

Submission Summary (Full Text)

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K101321

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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.,<br>Industrial Park, P.O.B. 550<br>Yokneam Illit, 20692, Israel |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Avi Hirshnzon<br>VP of QA and Regulatory Affairs<br>Tel : + 972 54 330 3402, + 972 732 442 200, Ext. 254<br>Fax : + 972 732 442 202<br>E-mail : [e-mail] |
| Trade Name: | eMatrix CO2 |
| Common name: | CO2 laser system |
| Classification: | Name: powered laser surgical instrument<br>Product Code: GEX<br>Regulation No: 878.4810<br>Class: II<br>Classification Panel: General & Plastic Surgery |
| Predicate Devices: | Substantial equivalence to the following predicate devices is<br>claimed:<br>1. Fraxel III SR Laser System (Fraxel re:pair™) and accessories<br>K071051; Reliant Technologies.<br>2. Alma Lasers Family of THERMO-XEL Handpieces Pixel Models:<br>2940, 1060 K072182; Alma Lasers<br>3. Alma Lasers THERMO-XEL CO2 Laser System and Delivery<br>Device Accessories K080463; Alma Lasers |

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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

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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

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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 [phone] or [phone] 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

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## 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