# K242184: Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: Dec 4, 2024 after 132 days
- Product code: MPA (Endoilluminator)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933880 (1994). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110951: 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula, Alcon Research, Ltd. (2011) Summary page 6.

## Cited in the summary but kept off the family tree
- K875005: Prisma Dispos. Brite Lite Fiberoptic Endoillumina., Advanced Surgical Products, Inc. (1988). Our reading of the summary gave K875005, FDA’s number for Prisma Dispos. Brite Lite Fiberoptic Endoillumina. (Advanced Surgical Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “25GA Chandelier”. Kept off the family tree. Summary page 6.

## Recalls of this device
- Aug 5, 2025 · Class II · Z-0304-2026: Due to incomplete seals in the pouch which provide the sterile barrier.
- Aug 5, 2025 · Class II · Z-0305-2026: Due to incomplete seals in the pouch which provide the sterile barrier.

## Indications for use
The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery. The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery. The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.

Source page: https://510kreport.com/device/K242184
Methodology: https://510kreport.com/methodology