FDA product code HQC: Unit, Phacofragmentation
HQC is the FDA product code for unit, phacofragmentation. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel. FDA has cleared 316 510(k) submissions under HQC, 15 in the last five years, from 120 different applicants. The average 510(k) review took 114 days (median 88); 201 days on average over the last three years. FDA has posted 74 recalls for HQC devices, 31 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Phacofragmentation |
| Device class | Class II |
| Regulation | 21 CFR 886.4670 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HQC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 202 |
| 2019 | 4 | 113 |
| 2020 | 4 | 217 |
| 2021 | 1 | 155 |
| 2022 | 4 | 198 |
| 2023 | 1 | 124 |
| 2024 | 5 | 182 |
| 2025 | 3 | 272 |
| 2026 | 2 | 148 |
Compare with all 510(k) review times · Search every HQC clearance
Top HQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Storz Instrument Co. | 17 | 1997-06-17 |
| Chiron Vision Corp. | 15 | 1996-04-24 |
| CooperVision, Inc. | 15 | 1989-05-09 |
| Site Microsurgical Systems, Inc. | 14 | 1994-02-16 |
| Abbott Medical Optics, Inc. | 9 | 2016-04-27 |
115 more applicants have HQC clearances. See the full list in Caduvo.
Most recent HQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261264 | Bausch and Lomb | 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+ | 2026-05-15 | 29 |
| K252052 | Bausch and Lomb, Incorporated | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | 2026-03-25 | 267 |
| K250501 | This AG | System Sophi | 2025-11-14 | 267 |
| K243395 | Carl Zeiss Meditec Cataract Technology, Inc. | MICOR 700 with Auto I/A | 2025-08-08 | 281 |
| K242801 | Carl Zeiss Meditec Cataract Technology, Inc. | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | 2025-06-11 | 267 |
Recalls for HQC devices
74 product recalls in 29 recall events; 31 initiated in the last five years and 32 still open. Most recent: 2025-08-05.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 1 |
| 2022 | 5 |
| 2023 | 8 |
| 2024 | 16 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code HQC?
HQC is the FDA product code for unit, phacofragmentation. It is a Class II device, regulated under 21 CFR 886.4670 and reviewed by the Ophthalmic panel.
What device class is HQC?
Class II, regulation 21 CFR 886.4670. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQC?
Across 316 cleared submissions the average was 114 days from receipt to decision (median 88).
Which companies have the most HQC clearances?
Storz Instrument Co. (17); Chiron Vision Corp. (15); CooperVision, Inc. (15); Site Microsurgical Systems, Inc. (14); Abbott Medical Optics, Inc. (9).
Have HQC devices been recalled?
Yes: 74 product recalls across 29 recall events; the most recent began 2025-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code HQC
- Run a recall and safety report across every HQC manufacturer
- Watch product code HQC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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