Eye Tech Care EyeOP1 and EYEOP-PACK - HSA Registration DE0501492
Access comprehensive regulatory information for Eye Tech Care EyeOP1 and EYEOP-PACK in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501492 and owned by EYE TECH CARE. The device was registered on April 09, 2018.
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.
This medical device (EyeOP1 control unit and associated EYEOP-PACK consumables) allows for non-invasive treatment of glaucoma via coagulation of part of the ciliary body by using focused ultrasound in order to reduce the production of aqueous humor and thereby to decrease the intraocular pressure (IOP). This treatment is called a UCP Procedure (“Ultrasound Cyclo Plasty”). This type of treatment is indicated for adult patients (over the age of 18) who are insufficiently responsive to medication and /or surgery-laser treatment and who have glaucoma characterized by ocular hypertension greater than or equal to: - 21 mmHg : for 6-sectors protocol. - 30 mmHg : for 8-sectors protocol. - 40 mmHg and no vision: for 10-sectors protocol.