Clearance Summary
Boston Keratoprosthesis, Type I Lucia received FDA 510(k) clearance under submission number K182986, sponsored by Massachusetts Eye and Ear Infirmary D/B/A Boston. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2019-01-30.
- Submission: K182986
- Applicant / Sponsor: Massachusetts Eye and Ear Infirmary D/B/A Boston
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3400
- Decision date: 2019-01-30
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.