FDA product code HJO: Biomicroscope, Slit-Lamp, Ac-Powered
HJO is the FDA product code for biomicroscope, slit-lamp, ac-powered. It is a Class II device, regulated under 21 CFR 886.1850 and reviewed by the Ophthalmic panel. FDA has cleared 109 510(k) submissions under HJO, 4 in the last five years, from 70 different applicants. The average 510(k) review took 126 days (median 92); 172 days on average over the last three years. FDA has posted 8 recalls for HJO devices.
Classification
| Field | Value |
|---|---|
| Device name | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.1850 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HJO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 209 |
| 2018 | 2 | 173 |
| 2020 | 1 | 57 |
| 2022 | 1 | 108 |
| 2024 | 1 | 266 |
| 2026 | 2 | 79 |
Compare with all 510(k) review times · Search every HJO clearance
Top HJO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carl Zeiss Meditec, AG | 8 | 2018-08-24 |
| Bausch & Lomb, Inc. | 4 | 2001-11-19 |
| Carl Zeiss, Inc. | 4 | 2000-03-20 |
| R.H. Burton Co. | 4 | 1993-04-14 |
| Takagi Seiko Co., Ltd. | 3 | 2017-04-14 |
65 more applicants have HJO clearances. See the full list in Caduvo.
Most recent HJO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262637 | Topcon Corporation | SLIT LAMP SL-D4 (Type: LED) | 2026-09-18 | 51 |
| K253834 | Carl Zeiss Vision GmbH | VISUREF 600 | 2026-03-18 | 107 |
| K231760 | Cylite Pty. , Ltd. | HP-OCT (HP-OCT) | 2024-03-08 | 266 |
| K222372 | Kowa Company , Ltd. | Kowa SL-19 | 2022-11-21 | 108 |
| K193188 | Medimaging Integrated Solution, Inc (Miis) | MiiS Horus Eye Anterior Camera | 2020-01-14 | 57 |
Recalls for HJO devices
8 product recalls in 6 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-04-15.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code HJO?
HJO is the FDA product code for biomicroscope, slit-lamp, ac-powered. It is a Class II device, regulated under 21 CFR 886.1850 and reviewed by the Ophthalmic panel.
What device class is HJO?
Class II, regulation 21 CFR 886.1850. Typical premarket route: 510(k).
How long does a 510(k) take for product code HJO?
Across 109 cleared submissions the average was 126 days from receipt to decision (median 92).
Which companies have the most HJO clearances?
Carl Zeiss Meditec, AG (8); Bausch & Lomb, Inc. (4); Carl Zeiss, Inc. (4); R.H. Burton Co. (4); Takagi Seiko Co., Ltd. (3).
Have HJO devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2021-04-15.
Next steps
- Run an FDA pathway report with predicate devices for product code HJO
- Run a recall and safety report across every HJO manufacturer
- Watch product code HJO 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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