FDA product code HLF: Device, Measuring, Lens Radius, Ophthalmic
HLF is the FDA product code for device, measuring, lens radius, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1430 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HLF, from 3 different applicants. The average 510(k) review took 87 days (median 41). FDA has posted 1 recall for HLF devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Measuring, Lens Radius, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.1430 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HLF clearance
Top HLF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marco Ophthalmic, Inc. | 1 | 1993-08-09 |
| Bausch & Lomb, Inc. | 1 | 1986-08-11 |
| Life-Tech Intl., Inc. | 1 | 1983-01-08 |
Most recent HLF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930437 | Marco Ophthalmic, Inc. | MARCO STANDARD RADIUSGAUGES | 1993-08-09 | 195 |
| K862517 | Bausch & Lomb, Inc. | BAUSCH & LOMB CONTACT LENS VIEWER | 1986-08-11 | 41 |
| K823767 | Life-Tech Intl., Inc. | ERG-JET ELECTRODE | 1983-01-08 | 25 |
Recalls for HLF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-05-19.
Frequently asked questions
What is FDA product code HLF?
HLF is the FDA product code for device, measuring, lens radius, ophthalmic. It is a Class I device, regulated under 21 CFR 886.1430 and reviewed by the Ophthalmic panel.
What device class is HLF?
Class I, regulation 21 CFR 886.1430. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLF?
Across 3 cleared submissions the average was 87 days from receipt to decision (median 41).
Which companies have the most HLF clearances?
Marco Ophthalmic, Inc. (1); Bausch & Lomb, Inc. (1); Life-Tech Intl., Inc. (1).
Have HLF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-05-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HLF
- Run a recall and safety report across every HLF manufacturer
- Watch product code HLF 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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