Latest News
Ever Fortune’s Hair Growth Cap Receives TFDA Medical Device Certification, Targets Hair Loss Treatment Market
2025-08-06

Ever Fortune announced on the 9th that its subsidiary, Ever Wynn Technology, jointly developed the Reness Hair Growth Cap, which has received medical device certification from Taiwan’s TFDA. The company plans to apply next for U.S. FDA approval, aiming to enter the international market with its hair growth technology.

To date, Ever Fortune has obtained a total of 49 medical device licenses domestically and internationally, including 13 from the U.S. FDA, 20 from Taiwan’s TFDA, 5 from Thailand, 5 from Malaysia, 5 from Vietnam, and 1 from Singapore. The Reness Hair Growth Cap marks Ever Fortune’s first certified medical device hardware product for production and sales.

Statistics show that approximately 1.6 billion people worldwide suffer from androgenic alopecia, with 1 in 5 people in Taiwan facing hair loss issues. The prevalence among men over 30 reaches 40%. The global hair loss treatment market reached USD 8.7 billion in 2023 and is projected to grow beyond USD 13.7 billion by 2028.

Ever Fortune noted that traditional hair loss treatments typically include oral medications (such as Finasteride and Dutasteride), topical solutions (like Minoxidil), and hair follicle transplantation. Recently, low-level laser therapy (LLLT) hair growth caps have emerged as a new option. The Reness Hair Growth Cap differs from traditional caps by utilizing Taiwan’s Macroblock’s latest ceramic packaging technology for its light sources. Compared to conventional plastic packaging, this offers superior performance, better heat dissipation, and longer lifespan.

The Reness Hair Growth Cap innovatively combines 660nm low-level laser light with 830nm LED red light. The 660nm laser penetrates the scalp surface to activate follicular mitochondria, promote stem cell proliferation, and extend the hair follicle growth phase. The 830nm LED red light penetrates deeper into the follicle’s structure, improving scalp microcirculation and reducing inflammation and oxidative stress.

Beyond the newly launched hair growth cap, Ever Fortune integrates its previously marketed deer antler exosome hair tonic and upcoming scalp delivery device and AI-powered hair care app—collectively known as the “Four Treasures” of hair care—forming a diversified and comprehensive hair growth technology platform. This full platform is scheduled for its debut at the Asia Beauty, Skincare & Biotechnology Expo from July 23 to 27.

In addition to continued achievements in medical AI this year, Ever Fortune’s technological capabilities have expanded into medical-related hardware devices. Its joint venture with Phison Electronics, Changlian Technology, plans to launch a generative AI care robot prototype in September and has committed to serving as a key partner for multiple medical institutions applying for the Healthy Taiwan Deep Cultivation Program.

Resource: 長佳智能生髮帽獲TFDA醫療認證 搶攻掉髮治療商機

Information appearing on this website (images and texts, unless otherwise indicated) is the property of IBMI. To use or share, please indicate the source.
© 2026 Institute for Biotechnology and Medicine Industry (IBMI) All rights reserved.
Address:9F., No. 508, Sec. 7, Zhongxiao E. Rd., Nangang Dist., Taipei City , Taiwan (R.O.C.) Contact Number:(02)2655-8168 Fax:(02)2655-7978