Cleared Special

K182986 - Boston Keratoprosthesis, Type I Lucia (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182986 · Massachusetts Eye and Ear Infirmary D/B/A Boston · Ophthalmic device
Jan 2019
Decision
93d
Days
Class 2
Risk

K182986 is an FDA 510(k) clearance for the Boston Keratoprosthesis, Type I Lucia. Classified as Keratoprosthesis, Permanent Implant (product code HQM), Class II - Special Controls.

Submitted by Massachusetts Eye and Ear Infirmary D/B/A Boston (Boston, US). The FDA issued a Cleared decision on January 30, 2019 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3400 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K182986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2018
Decision Date January 30, 2019
Days to Decision 93 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 156d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HQM Keratoprosthesis, Permanent Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.