Lamp, Infrared, Non Heating
A Non-Heating Infrared Lamp is a Physical Medicine device that emits infrared radiation at wavelengths or intensities that do not produce a significant thermal effect in tissue, used for purposes such as vascular visualization, photobiomodulation therapy, or non-thermal phototherapy applications. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IOB, regulated under 21 CFR 890.5500, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.
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Basic Information
- Product Code
- IOB
- Device Class
- FDA class 2
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K903660 | DERMALIGHT PSORACOMB | Jul 17, 1991 | Substantially Equivalent | Solitec GmbH |
| K910091 | ULTRALITE PANELITE | May 30, 1991 | Substantially Equivalent | Ultralite |
| K842276 | SUNMASTER | Jul 16, 1984 | Substantially Equivalent | Mt. Hood Mfr., Inc. |
| K813451 | UVA FLUORESCENT TANNING LAMPS | Jan 28, 1982 | Substantially Equivalent | North American Philips Corp. |
| K812853 | OSRAM UVA LAMP | Dec 09, 1981 | Substantially Equivalent | Osram GmbH |
| K760519 | SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 | Sep 03, 1976 | Substantially Equivalent | Dermatron Corp. |