InLight FDA 510(k) CLEARANCE
The FDA defines a medical device that requires a 510(k) as “an instrument, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including a component part, or accessory which is intended to affect the structure or ANY function of the body of man …”.
If a product is used for “heat therapy to alleviate aches, pains, stiffness and muscle spasms” it falls under the definition of a MEDICAL DEVICE, which is then further classified based on the specifics of the device. There are only two possible regulations identified for this type of device. There is only ONE possible regulation if any part of your system contains infrared utilization. If the product contains infrared, it cannot be classified as a spa product as opposed to a medical device.
Sec. 890.5500 Infrared Lamp
(a). Identification – An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies to provide topical heating.
(b) Classification. Class II (Performance Standards)
The FDA has determined that the Infrared Devices pose more of a risk to safety and efficacy, so a pre-market submission [510(k)] clearance is REQUIRED prior to marketing.
The only way to legally market this type of device is through an obtained 510(k) clearance.
Our LED light systems are considered Class II Medical Devices with a FDA 510(k) clearance.
FDA product listing
All InLight Medical devices are FDA cleared. The FDA classification code is 890.5500, clearance K153389.
The InLight Medical manufacturing facility is an FDA registered facility and subject to regulation and inspection requirements.