Krypton Vision (Suzhou) Ltd.

Krypton Vision (Suzhou) Ltd. specializes in optical devices used in eye care, with a focus on phoropters. Phoropters are essential tools in optometry and ophthalmology, used to measure refractive errors and assess visual acuity during routine eye examinations. The company’s primary product, like the IwavePhoropter, falls under this category.

Krypton Vision (Suzhou) Ltd. is based in the United States. While the company’s location influences its regulatory obligations, it is important to note that individual devices—not the manufacturer—are subject to authorization processes. The company’s devices are classified as Class I, which typically involves lower regulatory scrutiny compared to higher-risk devices.

Yes, Krypton Vision’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and transparency in the supply chain, helping healthcare providers verify the identity and regulatory status of the devices they use. The UDI system is a key component of medical device tracking and compliance.

Krypton Vision’s devices are classified as Class I medical devices. This classification generally means they pose minimal risk to patients and are subject to the lowest level of regulatory control. Class I devices typically require basic manufacturing practices and may not need pre-market approval, though compliance with good manufacturing practices (GMP) remains essential.