Cleared Traditional

Cornisol

K221759 · Aurolab · Ophthalmic

Oct 2022

Decision

110d

Days

—

Risk

About This 510(k) Submission

K221759 is an FDA 510(k) clearance for the Cornisol, a Media, Corneal Storage, submitted by Aurolab (Veerapanjan, Madurai, IN). The FDA issued a Cleared decision on October 5, 2022, 110 days after receiving the submission on June 17, 2022. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K221759 FDA.gov
FDA Decision	Cleared 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