FDA.report

LuxPen Microneedling Cartridges

Primary DI
00860015460646
Brand
LuxPen Microneedling Cartridges
Company
T AESTHETICS LLC
Model
MP1209SP
Published
2026-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
QAIPowered Microneedle Device

Product Code Classifications

CodeDeviceSpecialtyClass
QAIPowered Microneedle DeviceGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860015460646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015460646008600154606468600154606460860015460646

GMDN Terms

TermDefinition
Water jet flosserAn electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility.

Sterilization Methods

Method

Regulatory Flags

DUNS number
104436248
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00860015460608LuxPenMP1209SP2026-03-12
00860015460615NextGen Aesthetics CO2FG900-S2026-03-12
00860015460622NextGen Aesthetics IPLVE20002026-03-12
00860015460639NextGen Aesthetics LHRFG2000-D+2026-03-12

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EMTDEMNPA4806USAMP06-MNP 1.5 ToskaniMED USAMT.DERM GmbHQAI2026-05-22
EMTDEMNPA4906USMP06-MNP 1.5 Exceed USMT.DERM GmbHQAI2026-05-22
EMTDEMNPEX4906USMP06-MNP 1.5 Exceed II 2.0MT.DERM GmbHQAI2026-05-22
EMTDEMNPEY06USMP06-MNP 1.5 Exceed II 3.0MT.DERM GmbHQAI2026-05-22
00860015460608LuxPenT AESTHETICS LLCQAI2026-03-12
00666151621244PRO Pen 14-Pin Microneedling CartridgeDermalogica, LLCQAI2026-01-31
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080555980600511NEED ProCAMPOMATS SRLQAI2025-12-03
080555980600821NEED Pro Cartridges CAMPOMATS SRLQAI2025-12-03
04260446131102XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
04260446131065XCELLARISPRO TWIST microneedling deviceDermaroller GmbHQAI2025-08-26
04260446131072XCELLARISPRO TWIST Control unitDermaroller GmbHQAI2025-08-26
04260446131089XCELLARISPRO TWIST HandpieceDermaroller GmbHQAI2025-08-26
04260446136268XCELLARISPRO Needling ModuleDermaroller GmbHQAI2025-08-26
B933EL03N029EllacorCytrellis Biosystems, Inc.QAI2025-06-12
00850061586018NanoPen Zizion Group Inc.QAI2024-12-26
B933ELCCV00EllacorCytrellis Biosystems, Inc.QAI2024-11-01
B933ELKIT03ellacorCytrellis Biosystems, Inc.QAI2024-11-01
00850060751004SkinPen Precision EliteBellus Medical, LLCQAI2024-10-01
00850060751011SkinPen Precision EliteBellus Medical, LLCQAI2024-10-01
00850060751073SkinPen Precision EliteBellus Medical, LLCQAI2024-10-01
00850060751035SkinPen Precision EliteBellus Medical, LLCQAI2024-10-01
B933EL03N020EllacorCytrellis Biosystems, Inc.QAI2024-09-12
B933EL03N02EllacorCytrellis Biosystems, Inc.QAI2024-09-12
06976749540012Dr.PenGUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD.QAI2024-08-06
B933ELKIT02ellacorCytrellis Biosystems, Inc.QAI2024-05-29