FDA.reportPublic FDA data

Ellacor

Primary DI
B933EL03N029
Brand
Ellacor
Company
Cytrellis Biosystems, Inc.
Model
EL-03N02
Catalog number
EL-03N02
Device description
Triple Needle Cartridge (1-Pack)
Published
2025-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K202517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202517000Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc.2021-07-09QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B933EL03N029PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8572541725customerservice@cytrellis.com

Regulatory Flags#

DUNS number
078440636
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B933ELKIT04ellacorEL-KIT04EL-KIT042025-12-16
B933ELKIT02ellacorEL-KIT02EL-KIT022024-05-29
B933ELSYS02R0ellacorEL-SYS02-REL-SYS02-R2025-10-20
B933ELCON02R0EllacorEL-CON02-REL-CON02-R2024-01-31
B933ELHPC02R0EllacorEL-HPC02-REL-HPC02-R2024-01-31
B933ELCON01R0EllacorEL-CON01-REL-CON01-R2023-06-05
B933ELHPC01R0EllacorEL-HPC01-REL-HPC01-R2023-06-05
B933ELCCV011EllacorEL-CCV01EL-CCV012024-11-01
B933ELCCV00EllacorEL-CCV01EL-CCV012024-11-01
B933ELKIT03ellacorEL-KIT03EL-KIT032024-11-01
B933EL03N021EllacorEL-03N02EL-03N022024-09-12
B933EL03N020EllacorEL-03N02EL-03N022024-09-12
B933EL03N02EllacorEL-03N02EL-03N022024-09-12
B933ELCLP011ellacorEL-CLP01EL-CLP012024-01-03
B933ELKIT010ellacorEL-KIT01EL-KIT012024-01-03
B933ELSYS02ellacorEL-SYS02EL-SYS022024-05-08
B933ELSYS01ellacorEL-SYS01EL-SYS012024-01-03
B933ELHPC02EllacorEL-HPC02EL-HPC022024-01-31
B933ELCCV010EllacorEL-CCV01EL-CCV012021-09-30
B933ELCON02ellacorEL-CON02EL-CON022024-01-03

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
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
B933ELCCV00EllacorCytrellis Biosystems, Inc.QAI2024-11-01