FDA product code HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic
HJK is the FDA product code for lens, contact, polymethylmethacrylate, diagnostic. It is a Class II device, regulated under 21 CFR 886.1385 and reviewed by the Ophthalmic panel. FDA has cleared 41 510(k) submissions under HJK, from 14 different applicants. The average 510(k) review took 82 days (median 58). FDA has posted 3 recalls for HJK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 886.1385 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HJK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 303 |
| 2020 | 1 | 63 |
Compare with all 510(k) review times · Search every HJK clearance
Top HJK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ocular Instruments, Inc. | 25 | 2002-03-04 |
| Volk Optical, Inc. | 4 | 2015-08-18 |
| Rxsight, Inc. | 1 | 2020-09-10 |
| Phakos | 1 | 2018-10-25 |
| Sensor Medical Technology, LLC | 1 | 2014-12-16 |
9 more applicants have HJK clearances. See the full list in Caduvo.
Most recent HJK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201909 | Rxsight, Inc. | RxSight Contact Lens | 2020-09-10 | 63 |
| K173944 | Phakos | Endocular Viewing Lenses and Silicone Ring | 2018-10-25 | 303 |
| K151961 | Volk Optical, Inc. | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | 2015-08-18 | 33 |
| K142715 | Sensor Medical Technology, LLC | Sensor Medical Family of Vitrectomy Lenses and Products | 2014-12-16 | 85 |
| K051630 | Insight Instruments, Inc. | SUPER VIEW DISPOSABLE BIOM LENS SET | 2005-06-29 | 12 |
Recalls for HJK devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-12-16.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code HJK?
HJK is the FDA product code for lens, contact, polymethylmethacrylate, diagnostic. It is a Class II device, regulated under 21 CFR 886.1385 and reviewed by the Ophthalmic panel.
What device class is HJK?
Class II, regulation 21 CFR 886.1385. Typical premarket route: 510(k).
How long does a 510(k) take for product code HJK?
Across 41 cleared submissions the average was 82 days from receipt to decision (median 58).
Which companies have the most HJK clearances?
Ocular Instruments, Inc. (25); Volk Optical, Inc. (4); Rxsight, Inc. (1); Phakos (1); Sensor Medical Technology, LLC (1).
Have HJK devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-12-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HJK
- Run a recall and safety report across every HJK manufacturer
- Watch product code HJK 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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