FDA product code HLS: Exophthalmometer
HLS is the FDA product code for exophthalmometer. It is a Class I device, regulated under 21 CFR 886.1270 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HLS. The average 510(k) review took 34 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Exophthalmometer |
| Device class | Class I |
| Regulation | 21 CFR 886.1270 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HLS clearance
Top HLS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Welch Allyn, Inc. | 1 | 1977-11-09 |
Most recent HLS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771900 | Welch Allyn, Inc. | 71110 DESK CHARGER | 1977-11-09 | 34 |
Recalls for HLS devices
openFDA lists no recalls for product code HLS.
Frequently asked questions
What is FDA product code HLS?
HLS is the FDA product code for exophthalmometer. It is a Class I device, regulated under 21 CFR 886.1270 and reviewed by the Ophthalmic panel.
What device class is HLS?
Class I, regulation 21 CFR 886.1270. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLS?
Across 1 cleared submissions the average was 34 days from receipt to decision (median 34).
Which companies have the most HLS clearances?
Welch Allyn, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLS
- Run a recall and safety report across every HLS manufacturer
- Watch product code HLS 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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