Cleared Traditional

K242184 - Alcon 27GA Chandelier (8065000252) (FDA 510(k) Clearance)

Also includes:
Alcon 27+ DS Wide Angle Endoilluminator (8065000253) Alcon 27+ DS Endoilluminator (8065000256)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242184 · Alcon Laboratories, Inc. · Ophthalmic device
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Dec 2024
Decision
132d
Days
Class 2
Risk

K242184 is an FDA 510(k) clearance for the Alcon 27GA Chandelier (8065000252). Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on December 4, 2024 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - the FDA ophthalmic device framework. 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 Alcon Laboratories, Inc. devices

Submission Details

510(k) Number K242184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2024
Decision Date December 04, 2024
Days to Decision 132 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
22d slower than avg
Panel avg: 110d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.