MX-7000 MICROXEL

K111831 · Bio-Med USA, Inc. · ONG · Dec 19, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111831
• Device Name: MX-7000 MICROXEL
• Applicant: Bio-Med USA, Inc.
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Dec 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MX-7000 CO2 laser system is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. This system can be used in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry. When used in fractionated mode, the MX-7000 CO2 system is intended to be used for ablative skin re-surfacing, Wrinkle, Fine lines, Ryhides, Furrow in Dermatology, in Plastic surgery, and in General surgery.

Device Story

MX-7000 is a CO2 laser system (10,600 nm) for soft tissue surgery and skin resurfacing. System components include an optic main bench assembly, articulated arm, LCD control panel, laser cooling system, handpieces (scanned/dynamic), and foot pedal. Operated by clinicians in clinical settings. Non-fractionated mode performs incision, excision, ablation, vaporization, and coagulation. Fractionated mode performs ablative skin resurfacing for wrinkles, fine lines, rhytides, and furrows. Clinician controls laser pulse power and selects handpieces to optimize effects for specific applications. Device provides surgical precision and controlled tissue interaction, benefiting patients through versatile surgical and dermatological treatment options.

Clinical Evidence

Bench testing only.

Technological Characteristics

CO2 laser system; 10,600 nm wavelength; fractional and non-fractional modes; articulated arm delivery; includes scanned and dynamic handpieces; cooling system; LCD control panel; foot pedal switch. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, vaporization, or coagulation in dermatology, plastic surgery, general surgery, gynecology, neurosurgery, and podiatry; or ablative skin resurfacing for wrinkles, fine lines, rhytides, and furrows in dermatology, plastic surgery, and general surgery.

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

• eCO2 Plus Laser (K100610)
• Edge CO2 Laser (K100590)

Submission Summary (Full Text)

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K1118,31 bygewtf@

DEC 1 9 2011

# Summary of safety and effectiveness

In accordance with Section 513 (1) of the SMDA as defined in 21CFR part 807.3 this summary is submitted to obtain Pre-Market 510 (K) notification.

# 1. Submitter / Contact person.

Mr. Young Chi. President Bio-Med USA Inc. ( Reg Nr. 2246683) 111 Ellison Street, Paterson, NJ 07505. U.S.A. Tel: [phone] Fax: [phone] e mail : biomedusa(@msn.com

## 2. Manufacturer

Dae Shin Enterprise. 401/2, 170-5 Gruo-dong, Guro-gu, Seoul, Korea Tel: [phone] Fax : [phone] Contact: K. Kim President

#### 3. Name of Device

| Trade name | MX-7000 MICROXEL |
|-------------------------|--------------------------------------------------------------------------|
| Classification name | Powered, Laser surgical instrument with Micro-<br>beam/Fractional output |
| Common name | CO2 Laser system |
| Regulation | 880.4810 |
| Class | II |
| Product Code | ONG |
| Subsequent product code | GEX |

#### 4. Legally marketed Predicate Device

| K100610 | eCO2 Plus Laser | Lutronic |
|---------|-----------------|------------|
| K100590 | Edge CO2 Laser, | JM Systems |

### 5. Device Description

MX-7000 Laser system utilize a Co2 module to generate a laser beam with wave length of 10.600 nm and used fractional or non fractional mode for different indication. The Doctor can optimize the effect for different applications by controlling the power of laser pulse and using different hand pieces.

The system are supplied with two hand pieces ( Scanned or/and Dynamic),depend the device configuration

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#### This system consist of

K111831 Page @ of @

Optic main Bench assembly, Articulated Arm LCD control panel, Laser Cooling system Hand pieces set, Foot Pedal switch.

Manufactured in accordance with both mandatory and voluntary standard

IEC 60601 Medical Electrical equipment part 1. General requirement for safety amend 2 1995 IEC60601-1-2 Electro magnetic compatibility test ED 2001 EMC test IEC60601-1-22-22: 1996 Particular requirement for the safety and Diagnostic of Therapeutic laser Equipment

#### 6. Intended use

MX-7000 CO2 laser system is indicated for use in non-fractionated mode is Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. This system can be used in Dermatology, Plastic surgery, General surgery, Gynecology, Neurosurgery, and in Podiatry.

When used in fractionated mode, the MX-7000 CO2 system is indicated for use ablative skin re-surfacing, Wrinkle, Fine line, Rhylides, Furrow in Dermatology, Plastic surgery, and in General surgery.

#### 7. Conclusion.

The D.S.E, MX-7000 Co2 system, in this submission, is substantially equivalent to several already cleared predicate device in respect to Intended use, Main function, Technology, Principal operation and performance.

So, it does not raise any additional concerns regarding safety and effectiveness.

Bio-Med USA will update and include in this summary any other information deemed seasonally necessary by the FDA

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 1 9 2011

Bio-Med USA, Inc. % Mr. Young Chi President 111 Ellison Street Paterson, New Jersey 07505

Re: K111831

Trade/Device Name: MX-7000, Microxel 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, GEX Dated: September 02, 2011 Received: December 13, 2011

Dear Mr. Chi:

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. Young Chi

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/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 yours,

Sincerely yours,

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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# Indication for use statement

510 (K) number : K111831

Device name : MX-7000, MICROXEL

Indication for use : MX-7000 CO2 laser system is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. This system can be used in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.

> When used in fractionated mode, the MX-7000 CO2 system is intended to be used for ablative skin re-surfacing, Wrinkle, Fine lines, Ryhides, Furrow in Dermatology, in Plastic surgery, and in General surgery.

Prescription use or/and Over the Counter use XX (Part 21 CFR 801 Sub part D ) (Part 21CFR 801 Sub part C)

Please do not write below line-continued an another pages if needed

Concurrence of CDRH, office of Device Evaluation ( ODE )

Nel R.P. Quiles for man

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111831