(174 days)
Not Found
No
The document describes a standard CO2 laser system with no mention of AI or ML capabilities in its intended use, device description, or specific sections for AI/ML information.
Yes
The device is used for incision, excision, ablation, vaporization, and coagulation of human soft tissues, and for ablative skin resurfacing, wrinkle, fine line, rhytides, and furrow treatment, which are all therapeutic procedures.
No
The MX-7000 CO2 laser system is described for surgical procedures involving incision, excision, ablation, vaporization, and coagulation of soft tissues, and for skin resurfacing. Its function is to treat or alter tissue, not to diagnose conditions.
No
The device description explicitly lists hardware components such as a CO2 module, optic main bench assembly, articulated arm, LCD control panel, laser cooling system, hand pieces, and a foot pedal switch. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the MX-7000 CO2 laser system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the MX-7000 is used for direct treatment of human body soft tissues through incision, excision, ablation, vaporization, and coagulation. It operates on the patient's body, not on samples taken from the body.
- The device description focuses on the laser technology and its application to tissue. There is no mention of analyzing biological samples or providing diagnostic information based on those samples.
Therefore, the MX-7000 CO2 laser system is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
ONG, GEX
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
This system consist of Optic main Bench assembly, Articulated Arm LCD control panel, Laser Cooling system Hand pieces set, Foot Pedal switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human body soft Tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dermatology, Plastic surgery, General surgery, Gynecology, Neurosurgery, and in Podiatry.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: 1 973 278 5222 Fax: 201 934 6030 e mail : biomedusa(@msn.com
2. Manufacturer
Dae Shin Enterprise. 401/2, 170-5 Gruo-dong, Guro-gu, Seoul, Korea Tel: 2 2025 1151 Fax : 2 2025 1154 Contact: K. Kim President
3. Name of Device
| Trade name | MX-7000 MICROXEL |
|---|---|
| Classification name | Powered, Laser surgical instrument with Micro- |
| 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
1
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
2
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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