RevLight 1029

GUDID B82110290

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); and 2. generally indicated to provide topical heating to promote increased blood flow, relaxation of muscle and relief of pain (Amber/Red Pulsators).

SUBCON MANUFACTURING CORP

Cosmetic red-light phototherapy system, professional

• Primary Device ID: B82110290
• NIH Device Record Key: cf91f6eb-1be6-4e13-a41e-a2b18acb91f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RevLight
• Version Model Number: 1029
• Catalog Number: 1029
• Company DUNS: 068492206
• Company Name: SUBCON MANUFACTURING CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8445066525
• Email: sales@rev-light.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B82110290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042630

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-12-20

On-Brand Devices [RevLight]

• B82110300: RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The b
• B82110290: RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The b
• B82110000: RevLight is a device that utilizes Light Emitting Diodes to provide LED light to the body. The b