Independent Survey on Safe Operation of Foreign Fractional CO2 Laser Devices | Verifying Power Compatibility and Domestic Operational Issues of Devices with Metal RF Tubes like ICONIC CO2 Pulse

*This release provides a summary of the results of an independent survey conducted by our company. *We do not recommend any specific products, procedures, medical treatments, adoption decisions, or use. *The results of this survey are based on information independently collected and analyzed by our company and do not guarantee specific efficacy, effectiveness, or safety in Japan. *Please make individual judgments regarding adoption and use by confirming the latest public information, related laws and regulations, lawful materials provided by device suppliers, and other necessary information.

MEDLAC Instrument and Consulting Co., Ltd. (Headquarters: Fukuoka City, Fukuoka Prefecture; Representative Director: Hideki Ogawa) has conducted an independent survey on the technical challenges and safety management systems regarding the domestic operation of foreign-made fractional CO2 laser devices, and is announcing the results.

Background of the Survey

Fractional CO2 lasers are widely recognized in the medical field as a technological category that emits carbon dioxide lasers with a wavelength of 10,600 nm in a fractional (dot-like) manner. In domestic medical institutions as well, the introduction of foreign fractional CO2 laser devices is increasing. On the other hand, when operating these foreign laser devices in Japan, technical verification information regarding power environments (differences between overseas 220V specs and Japan's commercial 100V/200V power), maintenance systems (differences between air-cooled and water-cooled methods), and laser tube types (technical differences between glass tube methods and Metal RF Tube methods) is currently insufficiently organized. As a provider of information on foreign medical devices, our company conducted this survey to fill this information gap and provide objective technical data necessary for domestic physicians when considering the introduction and operation of laser devices.

Summary of Survey Results

This survey verified and analyzed the following three items.

1. Survey on Power Compatibility of Foreign Fractional CO2 Laser Devices We collected and analyzed actual operational data in clinics regarding whether foreign-spec fractional CO2 laser devices (including foreign devices like the ICONIC CO2 Pulse) can maintain their designed rated output using Japan's commercial power (100V/200V). As a result, we obtained data on the operational status of laser outputs under Japan's commercial power environment. Please contact us for detailed response trends for each item.

2. Information Needs Survey on Maintenance Systems and Long-Term Operation We conducted a questionnaire on domestic physicians' information needs and operational concerns in the Japanese market regarding maintenance systems (differences in cooling methods, laser tube replacement cycles, etc.), which are crucial for the long-term operation of laser devices. As a result, we obtained data on the trends of information needs regarding maintenance systems and the direction of concern regarding long-term operational costs. Please contact us for detailed response trends for each item.

3. Technical Awareness Interview on Laser Tube Types (Metal RF Tube, etc.) Based on MDSAP-compliant manufacturing data disclosed from Taiwan, we confirmed the domestic physicians' awareness regarding the type of laser tubes installed in fractional CO2 laser devices. Specifically, we interviewed them about their grasp of the technical specifications of the Metal RF Tube method compared to the conventional glass tube method (such as uniformity of irradiation energy, maintenance-free cooling design due to the adoption of air cooling, and design intended for long-term use of 7 to 10 years). As a result, we obtained data on the awareness of the technical specifications of the Metal RF Tube method. Please contact us for detailed response trends for each item.

Future Outlook

Since our founding in 2019, our company has continuously listened to the needs of domestic physicians regarding foreign medical devices. This survey is part of that accumulation, triggered by a research request from a Taiwanese corporation regarding an MDSAP-certified device, and collects and analyzes the voices of physicians concerning technical issues related to safe domestic operation in the fractional CO2 laser field.

Please contact us for detailed analysis results of each survey item. Our company will continue to work on improving the transparency of information regarding foreign medical devices through the accumulation and publication of objective data.

Survey Overview

Item: Details Survey Period: January 15, 2025 - March 31, 2026 Survey Organization (Entity): MEDLAC Instrument and Consulting Co., Ltd. Research & Development Department Target Audience: Those who have used our foreign medical device provision support services in the past