Unity VCS (8065000296); Unity CS (8065000297)
FDA 510(k) K233876 · Alcon Laboratories, Inc.
510(k) numberK233876
Submission
- Device name
- Unity VCS (8065000296); Unity CS (8065000297)
- Applicant
- Alcon Laboratories, Inc.
Fort Worth, TX, US - Received
- December 7, 2023
- Decision date
- June 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
Other 510(k)s with product code HQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23…HQC · Special | Bausch and Lomb | 05/15/2026SE |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565…HQC · Traditional | Bausch and Lomb, Incorporated | 03/25/2026SE |
| K250501 | System SophiHQC · Traditional | This AG | 11/14/2025SE |
| K243395 | MICOR 700 with Auto I/AHQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 08/08/2025SE |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621)…HQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 06/11/2025SE |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)HQC · Traditional | Bausch and Lomb, Incorporated | 07/26/2024SE |
| K233398 | Faros Surgical SystemHQC · Traditional | Oertli Instrumente AG | 06/27/2024SE |
| K232084 | Stellaris Elite vision enhancement systemHQC · Traditional | Bausch and Lomb | 02/26/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | Alcon Laboratories, Inc. | 01/10/2024SE |
| K230858 | Quatera 700HQC · Traditional | Carl Zeiss Meditec, AG | 07/31/2023SE |
More from Carl Zeiss Meditec, AG
| 510(k) | Device | Decision |
|---|---|---|
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional | 02/13/2026SE |
| K252682 | LenSx Laser System (8065000944)OOE · Special | 09/24/2025SE |
| 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 |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…MPA · Traditional | 12/04/2024SE |
| 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 Unity VCS (8065000296); Unity CS (8065000297) cleared by the FDA?
Unity VCS (8065000296); Unity CS (8065000297) (K233876) received a 510(k) decision of Substantially Equivalent on June 21, 2024, 197 days after the submission was received.
What is the product code of K233876?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.