FDA.reportPublic FDA data

ELEVARE

Primary DI
16928336800358
Brand
ELEVARE
Company
zhongshan Bisen plastic electronic products CO,LTD
Model
700 PINK
Device description
OTC DEVICE TO TREAT WRINKLES
Published
2016-10-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26928336800355PackageGS110In Commercial Distribution
16928336800358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2692833680035526928336800355
1692833680035816928336800358

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
1-800-699-9340INFO@ZEROGRAVITYSKIN.COM

Regulatory Flags#

DUNS number
527942227
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16928336800365ELEVARE 700 BLACK2016-10-11
16928336800372PERFECTIO8502016-10-11
16928336800389PERFECTIO9002016-10-11
26928336800362ELEVARE 700 BLACK2016-10-11
26928336800379PERFECTIO8502016-10-11
26928336800386PERFECTIO9002016-10-11

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