FDA.reportPublic FDA data

Footswitch

Primary DI
EMTDE100201USMP0
Brand
Footswitch
Company
MT.DERM GmbH
Model
E100201USMP
Catalog number
E100201USMP
Device description
The Footswitch is an accessory of Exceed AD61USMP.
Published
2018-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K180778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180778000Exceed Microneedling DeviceMt. Derm GmbH2018-09-07QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMTDE100201USMP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electronic cosmetic micro-needling handpieceA non-sterile, hand-held, mains electricity (AC-powered) device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin (i.e., to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, hair loss) as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); the micro-needles are not part of the handpiece, however a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure60 KiloPascal107 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit
Storage Environment Atmospheric Pressure54 KiloPascal107 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329216357
Device count
1
Serial number
true
Manufacturing date on label
true

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
EMTDEMNPEX4906USMP06-MNP 1.5 Exceed II 2.0EMNPEX4906USMP2026-05-22
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
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
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
EMTDEMNPEX4906USMP06-MNP 1.5 Exceed II 2.0MT.DERM GmbHQAI2026-05-22
EMTDEMNPEY06USMP06-MNP 1.5 Exceed II 3.0MT.DERM GmbHQAI2026-05-22
08800016000443E-PENBOMTECH ELECTRONICS CO., LTD.QAI2026-04-29
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
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
00860012651016CytoPen NGEMAGE MEDICAL LLCQAI2025-05-22
00860012651030CytoPen S2EMAGE MEDICAL LLCQAI2025-05-22
00850061586018NanoPen Zizion Group Inc.QAI2024-12-26
B933ELCCV011EllacorCytrellis Biosystems, Inc.QAI2024-11-01