FDA.reportPublic FDA data

Zemits Bionexis Lite

Primary DI
00860009982482
Brand
Zemits Bionexis Lite
Company
Advance-Esthetic LLC
Model
2
Catalog number
10001
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009982482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009982482008600099824828600099824820860009982482

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

Regulatory Flags#

DUNS number
043911204
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010841181Zemits Quidion1311232025-10-26
00860013757533Zemits YAGenix11022232025-10-26
00860013757540Zemits CarbonFrax Pro11024232025-10-26
00860013757557Zemits DioPulse1410252025-10-26
00860010841150Zemits CelluSpice Pro13112512024-01-27
00860009982437Zemits CoolRestore Elegance1135222023-09-15
00860009982499Zemits EndoLuxx 21136222023-09-15
00860010841105Zemits Leger 220031812023-09-15
00860010841174Zemits DuoCratus11119212024-02-06
00860010841112Zemits Klein EL145182024-01-27
00860010841129Zemits Klein RF154882024-01-27
00860010841136Zemits Verstand HD12024-01-27
00860010841143Zemits JoliPeel11048232024-01-27
00860010841167Zemits OxiVelour11236212024-01-27
00860009982413Zemits CrystalFrax17770192023-09-15
00860009982444Zemits FrioLift21045222023-09-15
00860009982451Zemits HydroVerstand11036232023-09-15
00860009982468Zemits Adrinox151112023-09-15
00860009982475Zemits Abigon Pro 21149212023-09-15
00860009982420Zemits DermeLuxx17770192023-08-15

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