Cleared Traditional

K151061 - Cornea Cold

K151061 · Eurobio · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
108d
Days
-
Risk

K151061 is an FDA 510(k) clearance for the Cornea Cold. Classified as Media, Corneal Storage (product code LYX).

Submitted by Eurobio (Les Ulis, FR). The FDA issued a Cleared decision on August 6, 2015 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151061

510(k) Number K151061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2015
Decision Date August 06, 2015
Days to Decision 108 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 110d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

LYX Device Classification - Class 0,

Product Code LYX Media, Corneal Storage
Device Class -

Regulatory Consultant

International Medical
JESSICA BARRETT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

K151061 · Cornea Cold
Download PDF FDA Summary Eurobio