RevLight

Primary DI
B82110000
Brand
RevLight
Company
SUBCON MANUFACTURING CORP
Model
1000
Catalog number
1000
Device description
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).
Published
2019-12-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042630000REVLIGHT SKIN CARE SYSTEMSkincare Technology, Inc.2005-06-27GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B82110000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, professionalAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in a professional setting. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by healthcare personnel typically for patient body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8445066525sales@rev-light.com

Regulatory Flags#

DUNS number
068492206
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B82110290RevLight102910292019-12-20
B82110300RevLight103010302019-12-20

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