Clearance Summary
DIGNITY OPHTHALMIC SURGICAL SYSTEM received FDA 510(k) clearance under submission number K031404, sponsored by Phacor Inc., A Santen Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2003-05-22.
- Submission: K031404
- Applicant / Sponsor: Phacor Inc., A Santen Company
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 2003-05-22
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.