Clearance Summary
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM received FDA 510(k) clearance under submission number K062930, sponsored by Alcon Research, Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2006-11-08.
- Submission: K062930
- Applicant / Sponsor: Alcon Research, Ltd.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1760
- Decision date: 2006-11-08
Classification & Regulation
This clearance is catalogued under FDA product code NCF and 21 CFR 886.1760, within the Ophthalmic review panel as a Class I device.