Product code HQC: 510(k) clearances and predicates
Product code HQC covers Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+. FDA lists 316 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
316 clearances on file under product code HQC. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 5 |
| 2025 | 3 |
| 2026 so far | 2 |
Recent clearances
Newest HQC clearances in the FDA index, with applicant and decision date:
- K261264, Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+, applicant Bausch and Lomb, decided 2026-05-15. FDA record
- K252052, Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E), applicant Bausch and Lomb, Incorporated, decided 2026-03-25. FDA record
- K250501, System Sophi, applicant This AG, decided 2025-11-14. FDA record
- K243395, MICOR 700 with Auto I/A, applicant Carl Zeiss Meditec Cataract Technology, Inc., decided 2025-08-08. FDA record
- K242801, MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185), applicant Carl Zeiss Meditec Cataract Technology, Inc., decided 2025-06-11. FDA record
- K240169, Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455), applicant Bausch and Lomb, Incorporated, decided 2024-07-26. FDA record
- K233398, Faros Surgical System, applicant Oertli Instrumente AG, decided 2024-06-27. FDA record
- K233876, UNITY VCS (8065000296); UNITY CS (8065000297), applicant Alcon Laboratories, Inc., decided 2024-06-21. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E), System Sophi. Watch new HQC clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code HQC?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HQC clearances include Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+.
How many 510(k) clearances use product code HQC?
316 at the time this page was generated, from openFDA records.
How do I find a predicate device under HQC?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new HQC clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.