Duns Number:068492206
Device Description: RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The base unit contains the power supplies, the control unit, and sets of Pulsators that deliver the light to the skin. The output of the Pulsators ranges from 420-940nm. RevLight is intended for use to provide LED light to the body. Depending on the wavelength(s) of light delivered by the Pulsators, RevLight is:1. generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsators); and2. generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).
Catalog Number
1000
Brand Name
RevLight
Version/Model Number
1000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K042630
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
0f2207cf-94e5-461a-b896-e46b230be25f
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
December 20, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |