FDA.reportPublic FDA data

CoolBreeze

Primary DI
00818257020081
Brand
CoolBreeze
Company
GENESIS BIOSYSTEMS, INC.
Model
D11-0318-504
Device description
Cool Breeze LED wand - Blue
Published
2017-04-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K131142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131142000GENESIS LED WANDSGenesis Biosystems, Inc.2013-11-27GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818257020081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818257020081008182570200818182570200810818257020081

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn 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 the home. 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 the patient typically for self 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
972-315-7888customerservice@genesisbiosystems.com

Regulatory Flags#

DUNS number
067933700
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818257022122Derma Genesis InfusionD11-0358-101D11-0358-1012023-07-24
00818257020012LipiVage®D11-0290-1082017-04-21
00818257020029LipiVage®D11-0290-1092017-04-21
00818257020074CoolBreezeD11-0318-5032017-04-21

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