FDA product code HLM: Instrument, Measuring, Lens, Ac-Powered
HLM is the FDA product code for instrument, measuring, lens, ac-powered. It is a Class I device, regulated under 21 CFR 886.1425 and reviewed by the Ophthalmic panel. FDA has cleared 16 510(k) submissions under HLM, from 12 different applicants. The average 510(k) review took 120 days (median 119). FDA has posted 1 recall for HLM devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Measuring, Lens, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1425 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HLM clearance
Top HLM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R.H. Burton Co. | 3 | 1993-04-05 |
| Marco Ophthalmic, Inc. | 2 | 1993-07-06 |
| Nidek, Inc. | 2 | 1988-11-23 |
| Leica, Inc. | 1 | 1994-11-17 |
| Hoya Corp. USA | 1 | 1994-09-29 |
7 more applicants have HLM clearances. See the full list in Caduvo.
Most recent HLM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944022 | Leica, Inc. | LENSCHEK | 1994-11-17 | 92 |
| K940997 | Hoya Corp. USA | AL-3300 | 1994-09-29 | 209 |
| K936199 | Canon USA, Inc. | AUTOMATIC LENSOMETER | 1994-09-28 | 273 |
| K930441 | Marco Ophthalmic, Inc. | MARCO STANDARD LENSMETERS 101,201 | 1993-07-06 | 161 |
| K930445 | Marco Ophthalmic, Inc. | MARCO LM-770 DIGITAL PROJECTION LENSMETER | 1993-06-21 | 146 |
Recalls for HLM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-06.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code HLM?
HLM is the FDA product code for instrument, measuring, lens, ac-powered. It is a Class I device, regulated under 21 CFR 886.1425 and reviewed by the Ophthalmic panel.
What device class is HLM?
Class I, regulation 21 CFR 886.1425. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLM?
Across 16 cleared submissions the average was 120 days from receipt to decision (median 119).
Which companies have the most HLM clearances?
R.H. Burton Co. (3); Marco Ophthalmic, Inc. (2); Nidek, Inc. (2); Leica, Inc. (1); Hoya Corp. USA (1).
Have HLM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code HLM
- Run a recall and safety report across every HLM manufacturer
- Watch product code HLM 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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