RevLight - RevLight is a device that utilizes Light Emitting - SUBCON MANUFACTURING CORP

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 and the control unit. Attachable to the base unit are three sets of Pulsators that deliver the light to the skin as they are moved over the skin surface. 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 detachable Pulsators that are connected to the base unit, 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).

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More Product Details

Catalog Number

1029

Brand Name

RevLight

Version/Model Number

1029

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

cf91f6eb-1be6-4e13-a41e-a2b18acb91f7

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

December 20, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUBCON MANUFACTURING CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3