Cleared Traditional

K221759 - Cornisol

K221759 · Aurolab · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
110d
Days
-
Risk

K221759 is an FDA 510(k) clearance for the Cornisol. Classified as Media, Corneal Storage (product code LYX).

Submitted by Aurolab (Veerapanjan, Madurai, IN). The FDA issued a Cleared decision on October 5, 2022 after a review of 110 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.

View all Aurolab devices

FDA 510(k) Submission Details - K221759

510(k) Number K221759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2022
Decision Date October 05, 2022
Days to Decision 110 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
At panel average
Panel avg: 110d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

LYX Device Classification - Class 0,

Product Code LYX Media, Corneal Storage
Device Class -

Regulatory Consultant

Allied Regulatory Consulting
Sean Griffin

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.