FDA product code HLQ: Keratoscope, Ac-Powered
HLQ is the FDA product code for keratoscope, ac-powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel. FDA has cleared 29 510(k) submissions under HLQ, from 22 different applicants. The average 510(k) review took 91 days (median 75).
Classification
| Field | Value |
|---|---|
| Device name | Keratoscope, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HLQ clearance
Top HLQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Computed Anatomy, Inc. | 3 | 1994-12-07 |
| Kera Corp. | 3 | 1990-05-30 |
| Nidek, Inc. | 3 | 1986-07-23 |
| Canon USA, Inc. | 2 | 1989-10-31 |
| Nidek Co., Ltd. | 1 | 2001-03-09 |
17 more applicants have HLQ clearances. See the full list in Caduvo.
Most recent HLQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003299 | Nidek Co., Ltd. | OPD-SCAN, MODELS ARK-10000 AND ARK-9000 | 2001-03-09 | 140 |
| K973756 | Eyesys Technologies, Inc. | EYE SYS VISTA | 1997-11-13 | 42 |
| K964290 | Reichert Ophthalmic Instruments, Div. Leica, Inc. | EYECHEK | 1997-01-09 | 73 |
| K945382 | Expertech Assoc., Inc. | TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER | 1995-01-31 | 90 |
| K944207 | Computed Anatomy, Inc. | TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 | 1994-12-07 | 100 |
Recalls for HLQ devices
openFDA lists no recalls for product code HLQ.
Frequently asked questions
What is FDA product code HLQ?
HLQ is the FDA product code for keratoscope, ac-powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel.
What device class is HLQ?
Class I, regulation 21 CFR 886.1350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLQ?
Across 29 cleared submissions the average was 91 days from receipt to decision (median 75).
Which companies have the most HLQ clearances?
Computed Anatomy, Inc. (3); Kera Corp. (3); Nidek, Inc. (3); Canon USA, Inc. (2); Nidek Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLQ
- Run a recall and safety report across every HLQ manufacturer
- Watch product code HLQ 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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