FDA product code HLI: Ophthalmoscope, Ac-Powered
HLI is the FDA product code for ophthalmoscope, ac-powered. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel. FDA has cleared 87 510(k) submissions under HLI, from 38 different applicants. The average 510(k) review took 105 days (median 88). FDA has posted 7 recalls for HLI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ophthalmoscope, Ac-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 HLI clearance
Top HLI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Optovue, Inc. | 7 | 2016-02-11 |
| Carl Zeiss Meditec, Inc. | 7 | 2007-01-26 |
| Neitz Instruments Company, Ltd. | 7 | 1995-04-07 |
| Keeler Instruments, Inc. | 6 | 2006-05-23 |
| Talia Technology , Ltd. | 5 | 2006-08-23 |
33 more applicants have HLI clearances. See the full list in Caduvo.
Most recent HLI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153080 | Optovue, Inc. | RTVue XR OCT Avanti with AngioVue Software | 2016-02-11 | 111 |
| K150722 | Bioptigen, Inc. | EnFocus 2300, EnFocus 4400 | 2015-12-02 | 257 |
| K142953 | Optomedical Technologies GmbH | OCT-Camera | 2015-03-04 | 145 |
| K141638 | Propper Manufacturing Co., Inc. | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | 2014-09-17 | 90 |
| K133758 | Centervue S.P.A. | CENTERVUE MACULAR INTEGRITY ASSESSMENT | 2014-04-23 | 133 |
Recalls for HLI devices
7 product recalls in 6 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2021-11-03.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code HLI?
HLI is the FDA product code for ophthalmoscope, ac-powered. It is a Class II device, regulated under 21 CFR 886.1570 and reviewed by the Ophthalmic panel.
What device class is HLI?
Class II, regulation 21 CFR 886.1570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLI?
Across 87 cleared submissions the average was 105 days from receipt to decision (median 88).
Which companies have the most HLI clearances?
Optovue, Inc. (7); Carl Zeiss Meditec, Inc. (7); Neitz Instruments Company, Ltd. (7); Keeler Instruments, Inc. (6); Talia Technology , Ltd. (5).
Have HLI devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2021-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HLI
- Run a recall and safety report across every HLI manufacturer
- Watch product code HLI 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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