FDA product code IOB: Lamp, Infrared, Non Heating
IOB is the FDA product code for lamp, infrared, non heating. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Physical Medicine panel. FDA has cleared 6 510(k) submissions under IOB, from 6 different applicants. The average 510(k) review took 106 days (median 53).
Classification
| Field | Value |
|---|---|
| Device name | Lamp, Infrared, Non Heating |
| Device class | Class II |
| Regulation | 21 CFR 890.5500 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every IOB clearance
Top IOB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Solitec GmbH | 1 | 1991-07-17 |
| Ultralite | 1 | 1991-05-30 |
| Mt. Hood Mfr., Inc. | 1 | 1984-07-16 |
| North American Philips Corp. | 1 | 1982-01-28 |
| Osram GmbH | 1 | 1981-12-09 |
1 more applicants have IOB clearances. See the full list in Caduvo.
Most recent IOB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903660 | Solitec GmbH | DERMALIGHT PSORACOMB | 1991-07-17 | 341 |
| K910091 | Ultralite | ULTRALITE PANELITE | 1991-05-30 | 141 |
| K842276 | Mt. Hood Mfr., Inc. | SUNMASTER | 1984-07-16 | 38 |
| K813451 | North American Philips Corp. | UVA FLUORESCENT TANNING LAMPS | 1982-01-28 | 49 |
| K812853 | Osram GmbH | OSRAM UVA LAMP | 1981-12-09 | 57 |
Recalls for IOB devices
openFDA lists no recalls for product code IOB.
Frequently asked questions
What is FDA product code IOB?
IOB is the FDA product code for lamp, infrared, non heating. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Physical Medicine panel.
What device class is IOB?
Class II, regulation 21 CFR 890.5500. Typical premarket route: 510(k).
How long does a 510(k) take for product code IOB?
Across 6 cleared submissions the average was 106 days from receipt to decision (median 53).
Which companies have the most IOB clearances?
Solitec GmbH (1); Ultralite (1); Mt. Hood Mfr., Inc. (1); North American Philips Corp. (1); Osram GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IOB
- Run a recall and safety report across every IOB manufacturer
- Watch product code IOB 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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