FDA product code HLJ: Ophthalmoscope, Battery-Powered
HLJ is the FDA product code for ophthalmoscope, battery-powered. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel. FDA has cleared 47 510(k) submissions under HLJ, from 26 different applicants. The average 510(k) review took 123 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Ophthalmoscope, Battery-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.1570 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HLJ clearance
Top HLJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rudolf Riester GmbH & Co. KG | 6 | 1995-07-24 |
| Heine Optotechnik GmbH & Co. KG | 5 | 2015-05-18 |
| Neitz Instruments Company, Ltd. | 5 | 1995-03-28 |
| Keeler Instruments, Inc. | 3 | 2003-11-26 |
| R & D Batteries, Inc. | 3 | 1994-06-03 |
21 more applicants have HLJ clearances. See the full list in Caduvo.
Most recent HLJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142486 | Heine Optotechnik GmbH & Co. KG | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | 2015-05-18 | 256 |
| K142837 | Heine Optotechnik GmbH & Co. KG | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | 2015-01-29 | 121 |
| K131959 | Heine Optotechnik GmbH & Co. KG | HEINE MINI 3000(R) OPHTHALMOSCOPE | 2014-03-07 | 253 |
| K131961 | Heine Optotechnik GmbH & Co. KG | HEINE BETA 200(R) OPHTHALMOSCOPE | 2013-12-04 | 160 |
| K131719 | Medical Devices (Pvt) , Ltd. | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | 2013-10-30 | 140 |
Recalls for HLJ devices
openFDA lists no recalls for product code HLJ.
Frequently asked questions
What is FDA product code HLJ?
HLJ is the FDA product code for ophthalmoscope, battery-powered. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel.
What device class is HLJ?
Class II, regulation 21 CFR 886.1570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLJ?
Across 47 cleared submissions the average was 123 days from receipt to decision (median 62).
Which companies have the most HLJ clearances?
Rudolf Riester GmbH & Co. KG (6); Heine Optotechnik GmbH & Co. KG (5); Neitz Instruments Company, Ltd. (5); Keeler Instruments, Inc. (3); R & D Batteries, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code HLJ
- Run a recall and safety report across every HLJ manufacturer
- Watch product code HLJ 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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