Clearance Summary
PHACOFRAGMENTATION SYSTEM MEGATRON received FDA 510(k) clearance under submission number K002031, sponsored by Asclepion-Meditec AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-12-27.
- Submission: K002031
- Applicant / Sponsor: Asclepion-Meditec AG
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 2000-12-27
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.