Clearance Summary
MicroSTAAR Injector System Cartridges received FDA 510(k) clearance under submission number K152357, sponsored by STAAR Surgical Company. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2015-10-30.
- Submission: K152357
- Applicant / Sponsor: STAAR Surgical Company
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2015-10-30
Classification & Regulation
This clearance is catalogued under FDA product code KYB and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.