FDA 510(k) Clearance — K212561
510(k) Clearance Letter
% Dave Kim, Medical Device Regulatory Affairs
Mtech Group, 7505 Fannin St. Ste 610, Houston, TX 77054
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. You may, therefore, market the device, subject to the general controls provisions of the Act.
Compliance Requirements
- Registration and listing (21 CFR Part 807)
- Labeling (21 CFR Part 801)
- Medical device reporting (21 CFR Part 803)
- Good manufacturing practice / Quality System (21 CFR Part 820)
- Electronic product radiation control (Sections 531-542 of the Act)
- 21 CFR 1000-1050
Signed By
Colin K. Chen, for Long Chen, Ph.D.
Assistant Director, DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Indications for Use (FDA Form 3881)
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite
Traditional 510(k) Summary — K212561
I. Submitter
| Submitter | Ilooda Co., Ltd |
| HQ Address | 120, Jangan-ro 458 Beon-gil, Jangan-Gu, Suwon-Si, Gyeonggido, KOREA 16200 |
| Contact | Yun-Jung HA (yjha@ilooda.com) / RD Manager |
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) 7505 Fannin St, Suite 610, Houston, TX 77054 |
Proposed Device
| Trade Name | MTX-C1 |
| Common Name | Electrosurgical cutting and coagulation device and accessories |
| Regulation | 21 CFR 878.4400 (Product Code: PBX) |
| Class | Class II |
Predicate Device
| Trade Name | Venus Legacy CX |
| 510(k) | K143554 |
| Regulation | 21 CFR 878.4400 (Product Code: PBX) |
| Class | Class II |
This predicate has not been subject to a design-related recall.
II. Device Description
The MTX-C1 main unit is a RF (Radio-frequency) energy generator employed for a variety of aesthetic applications. The Main unit output is set and monitored via touchscreen and controlled by a footswitch.
The system consists of:
- Main unit
- 3 type treatment handpiece (Small, Medium, Large)
- Footswitch
- Touch screen (User interface)
III. Indications for Use
- Relief of minor muscle aches and pain, relief of muscle spasm
- Temporary improvement of local blood circulation
- Temporary reduction in the appearance of cellulite
Technological Comparison with Predicate Device
| Feature | MTX-C1 (Proposed) | Venus Legacy CX (Predicate) |
|---|---|---|
| Manufacturer | Ilooda Co., Ltd | Venus Concept Ltd., Weston FL, USA |
| 510(k) | K212561 | K143554 |
| Product Code | PBX | PBX |
| Energy Type | RF energy | RF energy |
| Components | Main unit + 3 handpieces (S/M/L) + Footswitch + Touch screen | Main unit + 2 applicators (LB2/LF2) + Footswitch/finger switch + Touch screen |
| Frequency | 1 MHz ± 10% | 1 MHz ± 10% |
| Max Power | 55W @ medium/large, 7.5W @ small | Up to 150W |
| RF Mode | Bipolar | Bipolar |
| Materials | Biocompatible | Biocompatible |
| Power | 100-240V~, 50/60Hz | 100-120 VAC / 60Hz, 220-240 VAC / 50Hz |
Performance Data & Conclusions
V. Performance Data
Biocompatibility testing: Patient contact components and materials tested and validated according to ISO 10993-1. Identical to the predicate device.
Non-Clinical testing:
- IEC 60601-1 — Basic safety and essential performance: Fulfilled
- IEC 60601-1-2 — Electromagnetic compatibility: Fulfilled
- IEC 60601-2-2 — HF surgical equipment: Fulfilled
Performance bench testing: Three handpieces tested to achieve superficial skin temperature (40-45°C) and maintain it for the required therapy time. Testing data demonstrated substantial equivalence to the predicate device.
VI. Conclusions
The intended use of the MTX-C1 is within the scope of the predicate device. MTX-C1 system, from both a design and clinical perspective, uses similar or identical technology as the cited predicate device and has the same intended uses.
Based upon the predicted overall performance characteristics for the MTX-C1, Ilooda Co., Ltd., believes that no significant differences exist in the usage of its underlying technological principles between MTX-C1 and the cited predicate device.