Cleared Traditional

K242184 - Alcon 27GA Chandelier (8065000252)

Also marketed or referenced as:
Alcon 27+ DS Wide Angle Endoilluminator (8065000253) Alcon 27+ DS Endoilluminator (8065000256)

K242184 is an FDA 510(k) clearance for Alcon 27GA Chandelier (8065000252), manufactured by Alcon Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K242184 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K242184

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.

MPA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MPA Endoilluminator

All 31
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