FDA product code HLN: Gauge, Lens, Ophthalmic
HLN is the FDA product code for gauge, lens, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1420 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HLN, from 2 different applicants. The average 510(k) review took 76 days (median 76).
Classification
| Field | Value |
|---|---|
| Device name | Gauge, Lens, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1420 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HLN clearance
Top HLN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ascon Medical Instruments, Ltd. | 1 | 1985-09-05 |
| Edward Weck, Inc. | 1 | 1980-07-28 |
Most recent HLN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K852054 | Ascon Medical Instruments, Ltd. | CONTACT LENS LOUPE, INSPETION LOUPE | 1985-09-05 | 119 |
| K801466 | Edward Weck, Inc. | LEIGH MEASURING SCALE #7725 | 1980-07-28 | 34 |
Recalls for HLN devices
openFDA lists no recalls for product code HLN.
Frequently asked questions
What is FDA product code HLN?
HLN is the FDA product code for gauge, lens, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1420 and reviewed by the Ophthalmic panel.
What device class is HLN?
Class I, regulation 21 CFR 886.1420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLN?
Across 2 cleared submissions the average was 76 days from receipt to decision (median 76).
Which companies have the most HLN clearances?
Ascon Medical Instruments, Ltd. (1); Edward Weck, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLN
- Run a recall and safety report across every HLN manufacturer
- Watch product code HLN 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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