Disclaimer
Disclaimer:
- The information on this website about light therapy and OnLux is for general knowledge only and does not constitute professional medical advice.
- OnLux does not claim to cure any specific musculoskeletal injuries.
- A licensed physician should always assess the nature of your injury and determine if OnLux is appropriate for your treatment plan.
- Always consult a licensed physician before using OnLux or any light therapy device.
- OnLux is a prescription medical device (Rx) registered with the FDA under product code ILY.
Product Description:
- OnLux is an FDA registered infrared heating device.
- OnLux is designed to emit infrared light to help:
- Provide temporary relief for minor muscle and joint pain, arthritis, and muscle spasms
- Relieve stiffness
- Promote muscle tissue relaxation
- Temporarily increase local blood circulation in the treated area
Product FDA registration information:
OnLux is an FDA registered device.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=692825&lpcd=ILY
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H – MEDICAL DEVICES
PART 890 — PHYSICAL MEDICINE DEVICES
Subpart F – Physical Medicine Therapeutic Devices
Sec. 890.5500 Infrared lamp.
(a) 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.
(b) 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.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]