AMO iDesign Refractive Studio - HSA Registration DE0012788
Access comprehensive regulatory information for AMO iDesign Refractive Studio in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0012788 and owned by AMO Manufacturing USA LLC. The device was registered on April 22, 2013.
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 iDesign Refractive Studio is indicated for the measurement of corneal topography, pupillometry, keratometry, auto‐refraction, and wavefront aberrations (including coma, spherical aberrations, trefoil, and other higher order aberrations). It is also indicated for the calculation of wavefront‐guided Laser Assisted in Situ Keratomileusis (LASIK) treatments (Advanced CustomVue treatments) for myopia, hyperopia, and mixed astigmatism.