510(k) · Cleared
Recalled · Class II · 2025Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · MPA Endoilluminator
Cleared on Dec 4, 2024 as substantially equivalent to K110951 (Alcon Research, Ltd., 2011) after a 132-day review. Its family tree reaches back 8 generations to 1994. It has been recalled 2 times.
- Decided
- Dec 4, 2024
- Review
- 132 days
- Class
- Class II
- Product code
- MPA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to K933880 (1994). 42 ancestors in all, the oldest K844373 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 7 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 6 generations backK964074 Diolite 532Iriderm Div. · 1997
- 5 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 4 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 3 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 2 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 1 generation backK110951 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator…Alcon Research, Ltd. · 2011 · Recalled
- This deviceK242184 Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle…Alcon Laboratories, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −7 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −6 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −5 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −4 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −3 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −2 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −1 | K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+… | Alcon Research, Ltd. | 2011 | 1 |
| 0 (this device) | K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator… | Alcon Laboratories, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MPA device
- #1 K253468 Nova Eye iTrack™ 250A Canaloplasty…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K875005 | FDA’s K875005 is Prisma Dispos. Brite Lite Fiberoptic Endoillumina. 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…me (Product Code in Parentheses) Regulatory Class II 3. PREDICATE DEVICES For Alcon 27GA Chandelier: Predicate Device 25GA Chandelier 510(k) Number K875005 Classification 21 CFR 876.1500 Endoscope and accessories (MPA) Number and Name (Product Code in Parentheses) Regulator… | 1988 |
| * | K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Summary page 6…ame (Product Code in Parentheses) Regulatory Class II For Alcon 27+ DS Endoilluminator: Predicate Device 27+ Straight Endoilluminator 510(k) Number K110951 Classification 21 CFR 876.1500 Endoscope and accessories (MPA) Number and Name (Product Code in… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2025 | Class II | Z-0304-2026 | Process control | Due to incomplete seals in the pouch which provide the sterile barrier. |
| Aug 5, 2025 | Class II | Z-0305-2026 | Process control | Due to incomplete seals in the pouch which provide the sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 12 of the 42 ancestors have a recall of any class.
- 1 other device also cites its predicate K110951.
How does its category compare?
All MPA devicesMPA Endoilluminator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MPA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MPA
Too few MPA 510(k)s in any year since 2007 to give a median.
Recalls per year · MPA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPA
11in 2025
MAUDE reports naming product code MPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 62 |
| 2025 | 0 | — | 1 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242184 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242184: Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242184
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026