FDA.reportPublic FDA data

Zemits CarbonFrax Pro

Primary DI
00860013757540
Brand
Zemits CarbonFrax Pro
Company
Advance-Esthetic LLC
Model
1
Catalog number
102423
Published
2025-10-26
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013757540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013757540008600137575408600137575400860013757540

GMDN Terms#

Term, Definition table
TermDefinition
Light-energy skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
8889993996customer-support@advance-esthetic.us

Regulatory Flags#

DUNS number
043911204
Device count
1
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
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
00860009982482Zemits Bionexis Lite 2100012023-09-15
00860009982420Zemits DermeLuxx17770192023-08-15

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Primary DI, Brand, Company table
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08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16