Technolas ACE Advanced Corneal Explorer - HSA Registration DE0505957
Access comprehensive regulatory information for Technolas ACE Advanced Corneal Explorer in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505957 and owned by Technolas Perfect Vision GmbH. The device was registered on July 01, 2021.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The medical device ACE is a cataract and refractive imaging platform for ophthalmic imaging and analysis for the eye. The measurements are performed without physical contact to the eye. The ACE distinguishes between left and right eye. It is intended for visualization and measurements of the anterior segment of the eye and the measurement of axial length. The analysis covers: • Cornea - Cornea shape and thickness • Anterior segment analysis - Anterior chamber width, depth, volume, and angle parameters - Lens thickness • Axial Length • Pupil diameter • White-to-white distance • Images of the iris The recorded measurement data can be exported to be used to calculate patient-customized treatments by creating a laser ablation pattern for refractive surgery. The ACE also performs calculations to assist users in determining the power of the intraocular lens for implantation.