Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
FDA 510(k) K242184 · Alcon Laboratories, Inc.
510(k) numberK242184
Submission
- Device name
- Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
- Applicant
- Alcon Laboratories, Inc.
Fort Worth, TX, US - Received
- July 25, 2024
- Decision date
- December 4, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MPA – Endoilluminator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K253468 | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)MPA · Traditional | Nova Eye, Inc. | 08/10/2026SE |
| K233653 | Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00)…MPA · Traditional | Peregrine Surgical, LLC | 08/05/2024SE |
| K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemMPA · Abbreviated | Nova Eye Inc. (Business Name Nova Eye Medical) | 03/30/2023SE |
| K202670 | Nam illumination probe with chopperMPA · Traditional | Oculight , Ltd. | 08/20/2021SE |
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier IlluminatorMPA · Traditional | Peregrine Surgical , Ltd. | 09/11/2015SE |
| K143123 | Synergetics PHOTON EXMPA · Traditional | Synergetics | 02/24/2015SE |
| K080067 | Iscience Interventional Ophthalmic MicrocatheterMPA · Traditional | Iscience Interventional | 07/18/2008SE |
| K062895 | Xenon Brightstar Illumination System, Model 1266.XIIIMPA · Special | Dutch Ophthalmic Research Center International BV | 10/13/2006SE |
| K062259 | Iscience Surgical Fiberoptic Illuminator, Model Fi - 100MPA · Traditional | Iscience Surgical | 08/15/2006SE |
| K041108 | Iscience Surgical Ophthalmic MicrocannulaMPA · Traditional | Iscience Surgical Corporation | 06/22/2004SE |
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| K243896 | LenSx Laser System (8065998162)OOE · Traditional | 04/28/2025SE |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism…LPL · Special | 01/13/2025SE |
| K233876 | Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional | 06/21/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | 01/10/2024SE |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…LPL · Special | 12/29/2023SE |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…LPL · Traditional | 11/16/2023SE |
| K230785 | Precision1, Precision1 for AstigmatismLPL · Special | 04/20/2023SE |
| K222500 | Air Optix ColorsLPL · Special | 09/15/2022SE |
Questions and answers
When was Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); cleared by the FDA?
Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184) received a 510(k) decision of Substantially Equivalent on December 4, 2024, 132 days after the submission was received.
What is the product code of K242184?
The FDA product code is MPA – Endoilluminator, a Class II (moderate risk) device regulated under 21 CFR 876.1500.