EDGE CO2 LASER SYSTEM

K100590 · Jm System Co., Ltd. · ONG · Nov 10, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100590
• Device Name: EDGE CO2 LASER SYSTEM
• Applicant: Jm System Co., Ltd.
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Nov 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Edge CO2 Laser System emits 10,600nm wavelength laser energy; utilizes scanning optics to deliver thermal energy patterns to epidermis and upper dermis. System components include main body, color touch screen, arm, hand-piece, and foot switch. Operated by clinicians in medical settings. In non-fractionated mode, device performs soft tissue surgery (incision, excision, ablation, vaporization, coagulation). In fractionated mode, device performs ablative skin resurfacing. Benefits include precise tissue interaction for surgical and dermatological applications.

Clinical Evidence

Bench testing only. Histological study conducted on pigs to evaluate depth of penetration for each microdot. No clinical data provided.

Technological Characteristics

10,600nm CO2 laser; scanning optics for fractional delivery; system includes main body, color touch screen, arm, hand-piece, and foot switch.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues (non-fractionated mode) and ablative skin resurfacing (fractionated mode).

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

• Cynosure Affirm CO2 Laser (K081424)

Submission Summary (Full Text)

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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<br>481-1, Gasan-dong<br>Geumcheon-gu<br>Seoul, Korea 153-775 | SEP 30 2010 |
| Contact Person: | Mr. Su-Gun Lee | Received K31 |
| Telephone:<br>Fax:<br>Email: | 82(02)2163-0158 - phone<br>[phone] – fax<br>[e-mail] | |
| Preparation Date: | February 15, 2010 | |
| Device Trade Name: | Edge CO2 Laser System | |
| Common Name: | CO2 Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser<br>79-ONG, 21 CFR 878-4810 | |
| Legally Marketed Predicate<br>Device: | Cynosure Affirm CO2 Laser<br>K081424 | |
| Description of the Edge CO2<br>laser | The Edge CO2 laser has a wavelength of 10,600nm. CO2 fractional<br>laser uses scanning optics to deliver a pattern of thermal energy to<br>the epidermis and upper dermis. Device accessories include tip<br>attachments. This system consists of main body, color touch<br>screen, Arm, hand-piece and Foot switch. | |
| Intended use of the Edge CO2<br>laser | The Edge CO 2 laser when used in traditional non-fractionated<br>scanner mode is indicated for incision, excision, ablation,<br>vaporization, and coagulation of body soft tissues. | |
| | The Edge CO 2 laser when used in fractionated mode is indicated<br>for ablative skin resurfacing. | |
| Performance Data: | A study was conducted to show the depth of penetration for each<br>microdot using histology on pigs. | |
| Results of Clinical Study: | None | |
| Conclusion: | The Edge CO2 Laser System is substantially equivalent to the<br>previously cleared predicate devices that are currently in | commercial distribution |

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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.

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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 [phone] or [phone] 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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## 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

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510(k) Number K100590