Cleared Traditional

K211786 - Independent Corneal Viewing Chamber (IVC-21) (FDA 510(k) Clearance)

K211786 · Bausch & Lomb, Incorporated · Ophthalmic device
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Dec 2021
Decision
177d
Days
-
Risk

K211786 is an FDA 510(k) clearance for the Independent Corneal Viewing Chamber (IVC-21). Classified as Media, Corneal Storage (product code LYX).

Submitted by Bausch & Lomb, Incorporated (St. Louis, US). The FDA issued a Cleared decision on December 3, 2021 after a review of 177 days - an extended review cycle.

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.

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Submission Details

510(k) Number K211786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2021
Decision Date December 03, 2021
Days to Decision 177 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
67d slower than avg
Panel avg: 110d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -