FDA.reportPublic FDA data

LuxPen

Primary DI
00860015460608
Brand
LuxPen
Company
T AESTHETICS LLC
Model
MP1209SP
Published
2026-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QAIPowered Microneedle Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAIPowered Microneedle DeviceGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015460608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015460608008600154606088600154606080860015460608

GMDN Terms#

Term, Definition table
TermDefinition
Inert gas-enhanced electrosurgical system filterA device intended to prevent fluids and bacterial contaminants from entering an inert gas-enhanced electrosurgical system generator during surgical procedures. It is a meshed piece placed between the generator and the connected handpiece/electrode. This is a single-use device.

Sterilization Methods#

Method table
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
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015460646LuxPen Microneedling CartridgesMP1209SP2026-03-20
00860015460615NextGen Aesthetics CO2FG900-S2026-03-12
00860015460622NextGen Aesthetics IPLVE20002026-03-12
00860015460639NextGen Aesthetics LHRFG2000-D+2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMTDAD64901USMP0Bio Touch PrecisionMT.DERM GmbHQAI2026-05-22
EMTDCF104901USMP0Bio Touch AeroMT.DERM GmbHQAI2026-05-22
EMTDCG100206USMP0Exceed UnlimitedMT.DERM GmbHQAI2026-05-22
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
00860015460646LuxPen Microneedling CartridgesT AESTHETICS LLCQAI2026-03-20
00666151621244PRO Pen 14-Pin Microneedling CartridgeDermalogica, LLCQAI2026-01-31
00666151621305PRO Pen Microneedling SystemDermalogica, LLCQAI2026-01-31
B933ELKIT04ellacorCytrellis Biosystems, Inc.QAI2025-12-16
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