Cleared Traditional

K251320 - XTRA4 (FDA 510(k) Clearance)

K251320 · Al.Chi.Mi.A. S.R.L · Ophthalmic device
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Sep 2025
Decision
135d
Days
-
Risk

K251320 is an FDA 510(k) clearance for the XTRA4. Classified as Media, Corneal Storage (product code LYX).

Submitted by Al.Chi.Mi.A. S.R.L (Ponte San Nicolò, IT). The FDA issued a Cleared decision on September 11, 2025 after a review of 135 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 Al.Chi.Mi.A. S.R.L devices

Submission Details

510(k) Number K251320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2025
Decision Date September 11, 2025
Days to Decision 135 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
25d slower than avg
Panel avg: 110d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.