FDA product code HQD: Lens, Contact (Other Material) - Daily
HQD is the FDA product code for lens, contact (other material) - daily. It is a Class II device, regulated under 21 CFR 886.5916 and reviewed by the Ophthalmic panel. FDA has cleared 118 510(k) submissions under HQD, 12 in the last five years, from 47 different applicants. The average 510(k) review took 109 days (median 88); 108 days on average over the last three years. 21 PMA applications cite this product code. FDA has posted 5 recalls for HQD devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Contact (Other Material) - Daily |
| Device class | Class II |
| Regulation | 21 CFR 886.5916 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HQD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 92 |
| 2018 | 5 | 57 |
| 2019 | 2 | 69 |
| 2020 | 1 | 127 |
| 2021 | 3 | 133 |
| 2022 | 3 | 88 |
| 2023 | 3 | 157 |
| 2024 | 5 | 98 |
| 2026 | 1 | 119 |
Compare with all 510(k) review times · Search every HQD clearance
Top HQD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acuity Polymers, Inc. | 11 | 2024-11-01 |
| Contamac, Ltd. | 11 | 2022-03-17 |
| Paragon Vision Sciences | 10 | 2018-03-16 |
| Synergeyes, Inc. | 9 | 2016-11-15 |
| Menicon Co, Ltd. | 5 | 2011-02-03 |
42 more applicants have HQD clearances. See the full list in Caduvo.
Most recent HQD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253822 | Zhuhai Fitlens Medical Technology Co., Ltd. | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | 2026-03-27 | 119 |
| K242393 | Acuity Polymers, Inc. | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses | 2024-11-01 | 80 |
| K241398 | Tianjin Mastervision Technology Co., Ltd. | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | 2024-10-22 | 159 |
| K241571 | Boston Foundation For Sight, Inc. D/B/A Bostonsight | BostonSight® Specialty Lenses | 2024-08-14 | 75 |
| K240618 | Acuity Polymers, Inc. | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | 2024-04-03 | 29 |
Recalls for HQD devices
5 product recalls in 3 recall events; 2 initiated in the last five years and 0 still open. Most recent: 2025-06-10.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code HQD?
HQD is the FDA product code for lens, contact (other material) - daily. It is a Class II device, regulated under 21 CFR 886.5916 and reviewed by the Ophthalmic panel.
What device class is HQD?
Class II, regulation 21 CFR 886.5916. Typical premarket route: 510(k).
How long does a 510(k) take for product code HQD?
Across 118 cleared submissions the average was 109 days from receipt to decision (median 88).
Which companies have the most HQD clearances?
Acuity Polymers, Inc. (11); Contamac, Ltd. (11); Paragon Vision Sciences (10); Synergeyes, Inc. (9); Menicon Co, Ltd. (5).
Have HQD devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2025-06-10.
Next steps
- Run an FDA pathway report with predicate devices for product code HQD
- Run a recall and safety report across every HQD manufacturer
- Watch product code HQD 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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