Clearance Summary
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 received FDA 510(k) clearance under submission number K050933, sponsored by Medisurg , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2005-12-09.
- Submission: K050933
- Applicant / Sponsor: Medisurg , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4100
- Decision date: 2005-12-09
Classification & Regulation
This clearance is catalogued under FDA product code NCR and 21 CFR 886.4100, within the Ophthalmic review panel as a Class II device.