Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
FDA 510(k) clearance K242184 · decided 2024-12-04
Clearance details
- K-number
- K242184
- Device name
- Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
- Applicant
- Alcon Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-25
- Decision date
- 2024-12-04
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- MPA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constel recall (Z-0304-2026) | Alcon Research LLC | 2025-10-24 |
| Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constel recall (Z-0305-2026) | Alcon Research LLC | 2025-10-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S164) | Alcon Laboratories, Inc. | 2026-07-08 |
| Acrosof Posterior Chamber Intraocular Lens (P930014/S163) | Alcon Laboratories, Inc. | 2026-07-06 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S165) | Alcon Laboratories, Inc. | 2026-07-02 |
| FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S087) | Alcon Laboratories, Inc. | 2026-05-29 |
| AcrySof Single-Piece IOL (SA60AT); AcrySof IQ Aspheric IOL (SN60WF); AcrySof Aspheric UV-Absorbing IOL (SA60WF); AcrySof (P930014/S161) | Alcon Laboratories, Inc. | 2026-04-30 |
| Precision7; Precision7 for Astigmatism; Precision7 Multifocal (P220007/S007) | Alcon Laboratories, Inc. | 2026-03-11 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S162) | Alcon Laboratories, Inc. | 2026-03-02 |
| Air Optix Plus Hydraglyde (lotrafilcon B) Spherical and Multifocal Soft Contact Lenses for Extended Wear (P010019/S086) | Alcon Laboratories, Inc. | 2026-02-26 |