Clearance Summary
AMADEUS II EPIKERATOME received FDA 510(k) clearance under submission number K043150, sponsored by Sis Ltd., Surgical Instrument Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2005-01-31.
- Submission: K043150
- Applicant / Sponsor: Sis Ltd., Surgical Instrument Systems
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2005-01-31
Classification & Regulation
This clearance is catalogued under FDA product code HNO and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.