FDA product code HOH: Spectacle, Operating (Loupe), Ophthalmic
HOH is the FDA product code for spectacle, operating (loupe), ophthalmic. It is a Class I device, regulated under 21 CFR 886.4770 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HOH, from 3 different applicants. The average 510(k) review took 76 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Spectacle, Operating (Loupe), Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4770 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HOH clearance
Top HOH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| General Scientific Corp. | 1 | 1994-01-25 |
| Seiler Instrument & Mfg. Co., Inc. | 1 | 1988-02-19 |
| Exeter Instruments, Inc. | 1 | 1981-04-23 |
Most recent HOH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934494 | General Scientific Corp. | SURGITEL | 1994-01-25 | 132 |
| K875124 | Seiler Instrument & Mfg. Co., Inc. | LOW-POWER BINOCULAR LOUPE | 1988-02-19 | 66 |
| K810817 | Exeter Instruments, Inc. | EXETER OPERATING LOUPE | 1981-04-23 | 30 |
Recalls for HOH devices
openFDA lists no recalls for product code HOH.
Frequently asked questions
What is FDA product code HOH?
HOH is the FDA product code for spectacle, operating (loupe), ophthalmic. It is a Class I device, regulated under 21 CFR 886.4770 and reviewed by the Ophthalmic panel.
What device class is HOH?
Class I, regulation 21 CFR 886.4770. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOH?
Across 3 cleared submissions the average was 76 days from receipt to decision (median 66).
Which companies have the most HOH clearances?
General Scientific Corp. (1); Seiler Instrument & Mfg. Co., Inc. (1); Exeter Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOH
- Run a recall and safety report across every HOH manufacturer
- Watch product code HOH 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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