HQC — Unit, Phacofragmentation Class II
FDA product code HQC covers "Unit, Phacofragmentation", a Class II medical device regulated under 21 CFR 886.4670. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQC
- Device Class
- Class II
- Regulation Number
- 886.4670
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261264 | bausch and lomb | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pac | May 15, 2026 |
| K252052 | bausch and lomb, incorporated | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, | March 25, 2026 |
| K250501 | this | System Sophi | November 14, 2025 |
| K243395 | carl zeiss meditec cataract technology | MICOR 700 with Auto I/A | August 8, 2025 |
| K242801 | carl zeiss meditec cataract technology | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-5062 | June 11, 2025 |
| K240169 | bausch and lomb, incorporated | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | July 26, 2024 |
| K233398 | oertli instrumente | Faros Surgical System | June 27, 2024 |
| K233876 | alcon laboratories | UNITY VCS (8065000296); UNITY CS (8065000297) | June 21, 2024 |
| K232084 | bausch and lomb | Stellaris Elite vision enhancement system | February 26, 2024 |
| K233902 | alcon laboratories | Centurion Vision System (Active Sentry) (8065753057) | January 10, 2024 |
| K230858 | carl zeiss meditec | QUATERA 700 | July 31, 2023 |
| K214028 | carl zeiss meditec cataract technology | MICOR Lens Fragmentation System | September 9, 2022 |
| K222236 | carl zeiss meditec cataract technology | miCOR System Lens Fragmentation System | August 24, 2022 |
| K213467 | d.o.r.c. dutch ophthalmic research center (international) | EVA NEXUS Ophthalmic Surgical System | June 14, 2022 |
| K212241 | carl zeiss meditec | QUATERA 700 | April 19, 2022 |
| K203060 | johnson and johnson surgical vision | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced | March 12, 2021 |
| K200207 | carl zeiss meditec cataract technology | xPORT S Lens Fragmentation System | October 15, 2020 |
| K200584 | carl zeiss meditec cataract technology | xPORT 304 (miCOR) System Lens Fragmentation System | July 31, 2020 |
| K193376 | carl zeiss meditec | Visalis V500, Visalis S500 | June 15, 2020 |
| K192418 | raico | Phacoemulsification Needle (Tip) and Irrigation Sleeve | May 27, 2020 |