FDA.reportPublic FDA data

6-MNP 1.5 Exceed II 2.0

Primary DI
EMTDEMNPEX4906USMP0
Brand
6-MNP 1.5 Exceed II 2.0
Company
MT.DERM GmbH
Model
EMNPEX4906USMP
Device description
The Safety Needle Cartridge is an accessory of Exceed Unlimited (Bio Touch Aero).
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QAIPowered Microneedle Device

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233709000Exceed UnlimitedMt. Derm GmbH2024-02-23QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMTDEMNPEX4906USMP1PackageHIBCC8In Commercial Distribution
EMTDEMNPEX4906USMP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needling electronic handpiece cartridge, professionalA device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small, sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. It is not intended to be used for energy-based skin treatment. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
329216357
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EMTDE104902USMP0FootswitchE104902USMP2026-06-08
EMTDEMNPA4806USMP0Safety Needle Cartridge 6-MNP 1.5 Exceed USEMNPA4806USMP2024-01-10
EMTDAD64901USMP0Bio Touch PrecisionAD64901USMP2026-05-22
EMTDCF104901USMP0Bio Touch AeroCF104901USMP2026-05-22
EMTDCG100206USMP0Exceed UnlimitedCG100206USMP2026-05-22
EMTDEMNPA4806USAMP06-MNP 1.5 ToskaniMED USAEMNPA4806USAMP2026-05-22
EMTDEMNPA4906USMP06-MNP 1.5 Exceed USEMNPA4906USMP2026-05-22
EMTDEMNPEY06USMP06-MNP 1.5 Exceed II 3.0EMNPEY06USMP2026-05-22
EMTDAD61USMP0ExceedAD61USMPAD61USMP2018-10-23
EMTDAD61USMP1ExceedAD61USMPAD61USMP2018-10-23
EMTDEMNPAED06USMP0Safety Needle Cartridge 6-MNP 1.5 Exceed USEMNPAED06USMPEMNPAED06USMP2018-10-23
EMTD104802USMP0Footswitch E104802USMP 2024-01-10
EMTDAD64801USMP1ExceedAD64801USMP2024-01-10
EMTDE100201USMP0Footswitch E100201USMP E100201USMP 2018-10-23
EMTDE100201USMP1Footswitch E100201USMP E100201USMP 2018-10-23
EMTDEMNPA4206USMP0Safety Needle Cartridge 6-MNP 1.5 Exceed USEMNPA4206USMP2020-01-01
EMTDAD64201USMP0ExceedAD64201USMP2020-01-01
EMTDE104201USMP0Footswitch E104201USMP 2020-01-01
EMTDEMNPA4206USMP1Safety Needle Cartridge 6-MNP 1.5 Exceed USEMNPA4206USMP2020-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800118100348NAWoorhi Mechatronics Co., Ltd.QAI2026-09-04
08800118100355CODE-XWoorhi Mechatronics Co., Ltd.QAI2026-09-04
08800118100560NAWoorhi Mechatronics Co., Ltd.QAI2026-09-04
00810007534930SKINSTYLUS STERILOCK 12-PIN CARTRIDGE IN POUCHHydrafacial LLCQAI2026-08-19
00810007534947SKINSTYLUS STERILOCK 36-PIN CARTRIDGE IN POUCHHydrafacial LLCQAI2026-08-19
00810007534954SKINSTYLUS STERILOCK HILO CARTRIDGE IN POUCHHydrafacial LLCQAI2026-08-19
00860012651047CytoPen S2EMAGE MEDICAL LLCQAI2026-07-14
00860012651054CytoPen S2EMAGE MEDICAL LLCQAI2026-07-14
EMTDE104902USMP0FootswitchMT.DERM GmbHQAI2026-06-08
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
EMTDEMNPEY06USMP06-MNP 1.5 Exceed II 3.0MT.DERM GmbHQAI2026-05-22
08800016000443E-PENBOMTECH ELECTRONICS CO., LTD.QAI2026-04-29
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMHydrafacial LLCQAI2026-03-27
00860015460646LuxPen Microneedling CartridgesT AESTHETICS LLCQAI2026-03-20
00860015460608LuxPenT AESTHETICS LLCQAI2026-03-12
00666151621244PRO Pen 14-Pin Microneedling CartridgeDermalogica, LLCQAI2026-01-31
00666151621305PRO Pen Microneedling SystemDermalogica, LLCQAI2026-01-31
B933ELKIT04ellacorCytrellis Biosystems, Inc.QAI2025-12-16
080555980600681NEED ProCAMPOMATS SRLQAI2025-12-03
080555980600751NEED Pro Cartridges CAMPOMATS SRLQAI2025-12-03
080555980600511NEED ProCAMPOMATS SRLQAI2025-12-03
080555980600821NEED Pro Cartridges CAMPOMATS SRLQAI2025-12-03
B933ELSYS02R0ellacorCytrellis Biosystems, Inc.QAI2025-10-20
04260446131058XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
04260446131102XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
04260446131065XCELLARISPRO TWIST microneedling deviceDermaroller GmbHQAI2025-08-26