Clearance Summary
BOSTON KERATOPROSTHESIS OR BOSTON KPRO received FDA 510(k) clearance under submission number K121203, sponsored by Massachusetts Eye & Ear Infirmary. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2013-05-10.
- Submission: K121203
- Applicant / Sponsor: Massachusetts Eye & Ear Infirmary
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3400
- Decision date: 2013-05-10
Classification & Regulation
This clearance is catalogued under FDA product code HQM and 21 CFR 886.3400, within the Ophthalmic review panel as a Class II device.