IOB · Lamp, Infrared, Non Heating
Physical Medicine · 21 CFR 890.5500 · Class 2
Overview
| Product Code | IOB |
|---|---|
| Device Name | Lamp, Infrared, Non Heating |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 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 | DERMALIGHT PSORACOMB | Solitec GmbH | Jul 17, 1991 | SESE |
| K910091 | ULTRALITE PANELITE | Ultralite | May 30, 1991 | SESE |
| K842276 | SUNMASTER | Mt. Hood Mfr., Inc. | Jul 16, 1984 | SESE |
| K813451 | UVA FLUORESCENT TANNING LAMPS | North American Philips Corp. | Jan 28, 1982 | SESE |
| K812853 | OSRAM UVA LAMP | Osram GmbH | Dec 9, 1981 | SESE |
| K760519 | 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
