21 CFR 890.5500 — Lamp, Infrared, Therapeutic Heating
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5500
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | 2 | 229 | |
| IOB | Lamp, Infrared, Non Heating | 2 | 6 | 3rd Party |
| LBG | Device, Fluidized Therapy, Dry Heat | 2 | 1 | 3rd Party |
| NHH | Device, Discharge, Electrostatic (For Pain Relief) | 2 | 2 | 3rd Party |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 2 | 53 | |
| NZY | Light, Lymphedema Reduction, Low Energy | 2 | 1 | |
| OAP | Laser, Comb, Hair | 2 | 107 |
Special Controls
ILY — Lamp, Infrared, Therapeutic Heating
*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.
eCFR
IOB — Lamp, Infrared, Non Heating
*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.
eCFR
LBG — Device, Fluidized Therapy, Dry Heat
*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.
eCFR
NHH — Device, Discharge, Electrostatic (For Pain Relief)
*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.
eCFR
NHN — Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
*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.
eCFR
NZY — Light, Lymphedema Reduction, Low Energy
*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.
eCFR
OAP — Laser, Comb, Hair
*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.
eCFR
