Glan Electronics Co., Ltd.

Glan Electronics Co., Ltd. specializes in intense pulsed light (IPL) skin surface treatment systems. These devices are primarily used for non-invasive cosmetic procedures, such as hair removal and addressing skin concerns. Examples include the OBT-02 IPL Hair Removal system and the ONEBEAUTY series, which are designed for targeted skin treatments.

Glan Electronics Co., Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The intense pulsed light systems they manufacture fall under FDA Class II classification, which requires compliance with specific regulatory pathways like 510(k) premarket notifications and UDI listing to ensure authorised commercial distribution.

Glan Electronics Co., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and compliance with U.S. regulatory requirements for Class II devices, including IPL systems like the OBT-02 and ONEBEAUTY series.

Glan Electronics Co., Ltd.’s IPL skin treatment devices are classified as FDA Class II. This classification is based on their intended use for non-invasive cosmetic procedures, such as hair removal and skin rejuvenation. Class II devices require stricter regulatory oversight than Class I but do not carry the same level of risk as Class III devices, necessitating compliance with pathways like 510(k) submissions and UDI registration.