OPN XII UL
Device Facts
| Record ID | K871179 |
|---|---|
| Device Name | OPN XII UL |
| Applicant | Aragona AB Co. |
| Product Code | ILY · Physical Medicine |
| Decision Date | Apr 13, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
