Largan Medical Co., Ltd.

Largan Medical Co., Ltd. specializes in daily wear soft (hydrophilic) contact lenses, including standard single-vision, colored, and UV-blocking variants. Their portfolio also includes specialized lenses for correcting astigmatism and presbyopia, using materials like polymacon, ocufilcon D, methafilcon A, and hioxifilcon A. Additionally, the company produces a diagnostic system called the 'LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System,' designed for evaluating sleep-related conditions.

Largan Medical Co., Ltd. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, particularly for FDA-authorized products.

Largan Medical Co., Ltd.’s devices are recorded in the FDA’s 510(k) premarket notification database. This registry tracks Class II medical devices that require a premarket submission to demonstrate substantial equivalence to a legally marketed predicate device.

Largan Medical Co., Ltd.’s contact lenses and diagnostic systems are classified as Class II medical devices by the FDA. This classification requires manufacturers to comply with specific controls, including performance standards or post-market surveillance, to ensure safety and effectiveness without needing pre-market approval.

Largan Medical Co., Ltd.’s contact lenses are formulated as daily wear (hydrophilic) devices, meaning they are intended for single-use or short-term wear (typically removed and discarded at the end of each day). This design reduces the risk of infection and eye irritation associated with prolonged wear, aligning with common practices for soft contact lenses in clinical and consumer markets.