Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5500](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500) → IOB — Lamp, Infrared, Non Heating

# IOB · Lamp, Infrared, Non Heating

_Physical Medicine · 21 CFR 890.5500 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB

## Overview

- **Product Code:** IOB
- **Device Name:** Lamp, Infrared, Non Heating
- **Regulation:** [21 CFR 890.5500](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)
- **3rd-party reviewable:** yes

## Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

## Classification Rationale

Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K903660](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB/K903660.md) | DERMALIGHT PSORACOMB | Solitec GmbH | Jul 17, 1991 | SESE |
| [K910091](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB/K910091.md) | ULTRALITE PANELITE | Ultralite | May 30, 1991 | SESE |
| [K842276](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB/K842276.md) | SUNMASTER | Mt. Hood Mfr., Inc. | Jul 16, 1984 | SESE |
| [K813451](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB/K813451.md) | UVA FLUORESCENT TANNING LAMPS | North American Philips Corp. | Jan 28, 1982 | SESE |
| [K812853](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB/K812853.md) | OSRAM UVA LAMP | Osram GmbH | Dec 9, 1981 | SESE |
| [K760519](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB/K760519.md) | SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 | Dermatron Corp. | Sep 3, 1976 | SESE |

## Top Applicants

- Dermatron Corp. — 1 clearance
- Mt. Hood Mfr., Inc. — 1 clearance
- North American Philips Corp. — 1 clearance
- Osram GmbH — 1 clearance
- Solitec GmbH — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB)

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