HQC
- Product code
- HQC
- Device name
- Unit, Phacofragmentation
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.4670
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 316 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261264 | 2026-05-15 | Bausch and Lomb | Stellaris Elite vision enhancement system; Posterio… | |
| K252052 | 2026-03-25 | Bausch and Lomb, Incorporated | Stellaris Elite vision enhancement system (BL11145,… | |
| K250501 | 2025-11-14 | This AG | System Sophi | |
| K243395 | 2025-08-08 | Carl Zeiss Meditec Cataract Technology… | MICOR 700 with Auto I/A | — |
| K242801 | 2025-06-11 | Carl Zeiss Meditec Cataract Technology… | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); … | — |
| K240169 | 2024-07-26 | Bausch and Lomb, Incorporated | Stellaris Elite vision enhancement system (BL11145, … | FDA |
| K233398 | 2024-06-27 | Oertli Instrumente AG | Faros Surgical System | |
| K233876 | 2024-06-21 | Alcon Laboratories, Inc. | UNITY VCS (8065000296); UNITY CS (8065000297) | |
| K232084 | 2024-02-26 | Bausch and Lomb | Stellaris Elite vision enhancement system | FDA |
| K233902 | 2024-01-10 | Alcon Laboratories, Inc. | Centurion Vision System (Active Sentry) (806575305… |
Official FDA classification page: HQC
Classification and pathway per current FDA publications. Data from openFDA (CC0).