Clearance Summary
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM received FDA 510(k) clearance under submission number K073591, sponsored by Staar Surgical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2008-03-13.
- Submission: K073591
- Applicant / Sponsor: Staar Surgical Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2008-03-13
Classification & Regulation
This clearance is catalogued under FDA product code MSS and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.