FDA.reportPublic FDA data

Derma Genesis Infusion

Primary DI
00818257022122
Brand
Derma Genesis Infusion
Company
GENESIS BIOSYSTEMS, INC.
Model
D11-0358-101
Catalog number
D11-0358-101
Device description
Multi Modality Micro-Exfolaition system
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818257022122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818257022122008182570221228182570221220818257022122

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9723157888customerservice@genesisbiosystems.com

Regulatory Flags#

DUNS number
067933700
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818257020012LipiVage®D11-0290-1082017-04-21
00818257020029LipiVage®D11-0290-1092017-04-21
00818257020074CoolBreezeD11-0318-5032017-04-21
00818257020081CoolBreezeD11-0318-5042017-04-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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