Lianyungang Tiannuo Optical Instrument Co., Ltd.

Lianyungang Tiannuo Optical Instrument Co., Ltd. specializes in ophthalmic examination equipment. Their product range includes slit lamps for detailed eye inspections, manually-adjusted static stands to support ophthalmic instruments, trial lens sets for vision testing, and line-powered instrument tables for stable device placement. They also produce automated devices like lensmeters (for measuring lens power) and refractometers (for assessing eye focus), as well as manually-adjusted lensmeters and powered keratoscopes (for corneal mapping). All devices focus on enhancing eye care diagnostics.

The company is based in the United States. While the name suggests a Chinese origin, their operational headquarters and manufacturing presence are located within the US, aligning with regulatory and market requirements for their ophthalmic devices.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for ophthalmic equipment like slit lamps, refractometers, and lensmeters, which are classified under FDA’s Class I and Class II categories. Listing in the UDI database is a requirement for devices marketed in the US.

The company’s devices fall into two FDA classification categories: Class I (generally low-risk, such as manually-adjusted stands or trial lens sets) and Class II (moderate-risk, including automated lensmeters, refractometers, and powered keratoscopes). Classification depends on factors like device function, intended use, and potential health impact. Automated or powered devices typically require more stringent controls due to their complexity and direct patient interaction.