AMO ELITA Femtosecond Laser System - HSA Registration DE0508771
Access comprehensive regulatory information for AMO ELITA Femtosecond Laser System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508771 and owned by AMO Manufacturing USA LLC. The device was registered on December 18, 2023.
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 ELITA System is an ophthalmic femtosecond laser intended to create a corneal flap in patients undergoing LASIK surgery/other surgery/treatment requiring initial lamellar resection of the cornea. It is also intended for flapless refractive correction via lenticule creation and removal, which alters the curvature of the corneal surface so as to correct a patient’s refraction. It is indicated for corneal refractive lenticule removal in the reduction/elimination of myopia with and without astigmatism up to -12.00D sphere, up to -6.00D cylinder, with the sum of sphere and cylinder between -1.00D and -12.00D using minus cylinder convention. The system is indicated for patients who are 18 years of age/older, with documentation of stable manifest refraction over the past year as demonstrated by a change of ≤0.50D manifest refraction spherical equivalent (MRSE). It should only be operated by, or under the direct supervision of a trained physician with certification in laser safety.