Independent Survey on Public Certification Status of Foreign Laser Devices | Verifying Awareness of FDA and MDSAP Certifications for ICONIC PICO3 PRO, etc.

*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 to understand the actual state of awareness and information comprehension among domestic physicians regarding the public certification status of foreign laser devices, and is announcing the results.

Background of the Survey

Some foreign-made medical devices have obtained international public certifications such as the US FDA (Food and Drug Administration) and MDSAP (Medical Device Single Audit Program).

However, it has not been sufficiently investigated or organized to what extent domestic medical professionals understand the existence and meaning of these certifications.

As a provider of information on foreign medical devices, our company conducted this survey to grasp the objective information regarding manufacturers' quality control systems and the level of awareness among domestic physicians.

Summary of Survey Results

This survey verified and analyzed the following three items.

1. Survey on Awareness of Public Certifications (FDA, MDSAP, etc.) for Foreign Laser Devices

We conducted face-to-face interviews regarding the awareness of FDA and MDSAP certifications targeting domestic clinic physicians who have experience introducing or considering introducing foreign laser devices. As a result, we obtained data on the awareness of public certifications for foreign laser devices.

2. Questionnaire on the Impact of Certification Information on Device Adoption Considerations

We conducted a questionnaire to determine how much the information regarding the acquisition of FDA and MDSAP certifications affects actual considerations for introducing devices. As a result, we obtained data on the trends of how public certification information affects adoption decisions.

3. Awareness Interviews Regarding the Certification Status of ICONIC PICO3 PRO, etc.

Based on MDSAP-compliant manufacturing data disclosed from Taiwan, we interviewed domestic physicians about their awareness of FDA and MDSAP certification acquisition for picosecond laser-related devices distributed overseas, such as the "ICONIC PICO3 PRO." Through our independent investigation, it was objectively confirmed that the manufacturer of this device has acquired US FDA certification and MDSAP certification. As a result, we obtained data on domestic physicians' awareness of these certification statuses.

Please note that all of these are overseas certifications and do not indicate the legal status of individual approvals, certifications, or notifications within Japan.

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 their awareness of public certifications for foreign laser devices.

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: Domestic clinic physicians/directors who have used our foreign medical device provision support services in the past Valid Responses (Sample Size): 32 physicians with private practice experience (Number of physicians actually interviewed or surveyed) Survey Methods: 1. Awareness Survey: Face-to-face interviews on domestic physicians' awareness of FDA and MDSAP certifications. 2. Adoption Impact Survey: Questionnaire on the impact of public certification information on device adoption decisions. 3. Certification Awareness Interview: Interviews on awareness regarding the certification status of specific devices like ICONIC PICO3 PRO based on MDSAP-compliant manufacturing data from Taiwan.

About ICONIC PICO3 PRO ICONIC PICO3 PRO is in the medical field