FDA.reportPublic FDA data

Bio Touch Precision

Primary DI
EMTDAD64901USMP0
Brand
Bio Touch Precision
Company
MT.DERM GmbH
Model
AD64901USMP
Device description
The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. Exceed consists of - Control Unit - Handpiece with handpiece cable - Handpiece Holder - Power Supply - Instructions for Use
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180778000
K182407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180778000Exceed Microneedling DeviceMt. Derm GmbH2018-09-07QAI
K182407000Exceed Microneedling deviceMt. Derm GmbH2019-07-19QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMTDAD64901USMP1PackageHIBCC1In Commercial Distribution
EMTDAD64901USMP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needling electronic handpiece, professionalA hand-held, electrically-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 as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
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
false
Serial number
true
Manufacturing date on label
true
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
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
EMTDAD64201USMP0ExceedAD64201USMP2020-01-01
EMTDE104201USMP0Footswitch E104201USMP 2020-01-01
EMTDEMNPA4206USMP1Safety Needle Cartridge 6-MNP 1.5 Exceed USEMNPA4206USMP2020-01-01
EMTDAD61USMP0ExceedAD61USMPAD61USMP2018-10-23
EMTDAD61USMP1ExceedAD61USMPAD61USMP2018-10-23
EMTDE100201USMP0Footswitch E100201USMP E100201USMP 2018-10-23
EMTDE100201USMP1Footswitch E100201USMP E100201USMP 2018-10-23
EMTDEMNPAED06USMP0Safety Needle Cartridge 6-MNP 1.5 Exceed USEMNPAED06USMPEMNPAED06USMP2018-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00860015460608LuxPenT AESTHETICS LLCQAI2026-03-12
00666151621244PRO Pen 14-Pin Microneedling CartridgeDermalogica, LLCQAI2026-01-31
00666151621305PRO Pen Microneedling SystemDermalogica, 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
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B933ELCCV00EllacorCytrellis Biosystems, Inc.QAI2024-11-01
B933ELKIT03ellacorCytrellis Biosystems, Inc.QAI2024-11-01
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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