Search Results
Found 1 results
510(k) Data Aggregation
K Number
K150554Device Name
NuBrilliance Light Pain Therapy
Manufacturer
WELLQUEST INTERNATIONAL, INC.
Date Cleared
2015-10-06
(216 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
WELLQUEST INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nu Brilliance Light Pain Therapy system is an Over-The-Counter handheld device intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
Device Description
The NuBrilliance Light Pain Therapy device is a lightweight, light emitting diode (LED) device that emits light energy. The NuBrilliance Light Pain Therapy device is an Over-The-Counter (OTC), hand held, ergonomically designed pain relief device that uses the infrared lamp for therapeutic heating. The head consists of four (#4) visible diodes (red lights) in the 625 nm (±5%) spectrum, and (#56) fifty-six infrared diodes (purple lights) in the 940 nm (±5%) spectrum that are used in combination for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature. Treatment is controlled by the operator. There are no user settings or adjustments.
Ask a Question
Page 1 of 1