Clearance Summary
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE received FDA 510(k) clearance under submission number K101782, sponsored by Staar Japan. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2010-12-22.
- Submission: K101782
- Applicant / Sponsor: Staar Japan
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2010-12-22
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.