FDA product code HOF: Burr, Corneal, Manual
HOF is the FDA product code for burr, corneal, manual. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HOF. The average 510(k) review took 64 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Burr, Corneal, Manual |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HOF clearance
Top HOF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Visitec Co. | 1 | 1989-01-31 |
Most recent HOF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884924 | Visitec Co. | VISI-WIPE | 1989-01-31 | 64 |
Recalls for HOF devices
openFDA lists no recalls for product code HOF.
Frequently asked questions
What is FDA product code HOF?
HOF is the FDA product code for burr, corneal, manual. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HOF?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOF?
Across 1 cleared submissions the average was 64 days from receipt to decision (median 64).
Which companies have the most HOF clearances?
Visitec Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOF
- Run a recall and safety report across every HOF manufacturer
- Watch product code HOF 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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