wontech Japan Obtains Partial Change Approval for Manufacturing and Marketing of "Sandro Dual" Laser Device for Long-Term Hair Reduction
wontech Japan Co., Ltd. has announced that it has obtained partial change approval for the manufacturing and marketing of its "Sandro Dual" laser device for long-term hair reduction. This approval allows for an expanded spot size, enabling faster treatments.
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- 📰 Published: May 8, 2026 at 21:14
- 🔍 Collected: May 8, 2026 at 12:32
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wontech Japan Co., Ltd. (Chuo-ku, Tokyo; Representative Director: Yasuhito Tanaka; hereinafter, "the Company") is pleased to announce that it has obtained partial change approval for the manufacturing and marketing of its "Sandro Dual" laser device for long-term hair reduction from the Minister of Health, Labour and Welfare.
Sandro Dual is a composite laser device that has successively obtained certifications in major recent regulatory markets, following US FDA certification, Taiwan's TFDA in January this year, and manufacturing and marketing approval based on Japan's Pharmaceutical and Medical Device Act at the end of March.
The Sandro Dual, which has obtained this partial change approval, is applicable for long-term hair reduction treatments. It features a "hybrid mode" that continuously irradiates two wavelengths, 755nm and 1064nm, with a short time difference, allowing for the combination of different wavelength characteristics on the target area.
With this partial change approval, the maximum spot size, which was up to 20mm in the conventional model, has been expanded to 25mm, enabling even faster treatments.
◆ Product Overview
Medical Device Approval Number
30200BZI00026000
General Name
Neodymium YAG Laser (Alexandrite Laser)
Trade Name
Laser Device for Long-Term Hair Reduction Sandro Dual
Class Classification
Ⅲ
Highly Controlled Medical Device, Specified Maintenance Controlled Medical Device, Installation Controlled Medical Device
Purpose or Effect of Use
This product is a device intended for long-term hair reduction through the selective thermal action of a laser.
About wontech Japan Co., Ltd.
wontech Japan Co., Ltd. is the Japanese subsidiary of wontech Co., Ltd., a medical device manufacturer based in Korea. It primarily provides advanced laser devices in the aesthetic medical field. Its parent company emphasizes research and development, and with its technological capabilities, it is expanding globally. In Japan, in addition to providing products to medical institutions, it also focuses on building trust with the medical community through academic conferences and seminars.
Company Name: WONTECH JAPAN Co., Ltd.
Representative Director: Yasuhito Tanaka
Location: Higashi Yaesu Place, 3-16-6 Hatchobori, Chuo-ku, Tokyo 103-0032
HP: https://wontech-japan.com/
Sandro Dual is a composite laser device that has successively obtained certifications in major recent regulatory markets, following US FDA certification, Taiwan's TFDA in January this year, and manufacturing and marketing approval based on Japan's Pharmaceutical and Medical Device Act at the end of March.
The Sandro Dual, which has obtained this partial change approval, is applicable for long-term hair reduction treatments. It features a "hybrid mode" that continuously irradiates two wavelengths, 755nm and 1064nm, with a short time difference, allowing for the combination of different wavelength characteristics on the target area.
With this partial change approval, the maximum spot size, which was up to 20mm in the conventional model, has been expanded to 25mm, enabling even faster treatments.
◆ Product Overview
Medical Device Approval Number
30200BZI00026000
General Name
Neodymium YAG Laser (Alexandrite Laser)
Trade Name
Laser Device for Long-Term Hair Reduction Sandro Dual
Class Classification
Ⅲ
Highly Controlled Medical Device, Specified Maintenance Controlled Medical Device, Installation Controlled Medical Device
Purpose or Effect of Use
This product is a device intended for long-term hair reduction through the selective thermal action of a laser.
About wontech Japan Co., Ltd.
wontech Japan Co., Ltd. is the Japanese subsidiary of wontech Co., Ltd., a medical device manufacturer based in Korea. It primarily provides advanced laser devices in the aesthetic medical field. Its parent company emphasizes research and development, and with its technological capabilities, it is expanding globally. In Japan, in addition to providing products to medical institutions, it also focuses on building trust with the medical community through academic conferences and seminars.
Company Name: WONTECH JAPAN Co., Ltd.
Representative Director: Yasuhito Tanaka
Location: Higashi Yaesu Place, 3-16-6 Hatchobori, Chuo-ku, Tokyo 103-0032
HP: https://wontech-japan.com/