FDA.reportPublic FDA data

SkinPen Precision Treatment Kits

Primary DI
20863221000327
Brand
SkinPen Precision Treatment Kits
Company
Bellus Medical, LLC
Model
1
Device description
Case of 18 single treatment kits.
Published
2018-05-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
DEN160029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160029000SkinPen Precision SystemBellus Medical, LLC2018-03-01QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20863221000327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086322100032720863221000327

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005677967
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060751738SkinPenF5SP5812026-05-20
00850060751028SkinPen Precision EliteREF015F5SP3882024-10-01
00850060751110ProGen PRP EclipseP5PG052PROGEN-A152024-08-28
00850060751158ProGen PRP EclipseP5PG053PROGEN-A302024-08-28
00850035498279SP MicroPen EVO Microneedling CartridgeF5SP2232022-05-25
00863221000323SkinPen Precision Treatment KitF5SP013F5SP0132018-04-09
00850060751004SkinPen Precision EliteREF200F5SP386, F5SP4182024-10-01
00850060751011SkinPen Precision EliteREF201F5SP387, F5SP419, F5SP4542024-10-01
00850060751103ProGen PRP EclipseP5PG0192024-08-28
00850060751141ProGen PRP EclipseP5PG0202024-08-28
00850035498262SP MicroPen EVOF5SP2162022-05-25
00850035498378Progen PRP EclipseTN15MLSINGLEF5PG013.022022-05-09
00850035498385Progen PRP EclipseTN30MLSINGLEF5PG014.022022-05-09
00850060751035SkinPen Precision EliteREF200/REF201F5SP3892024-10-01
00850035498873SkinPen Precision Premium Treatment KitF5SP391F5SP3912023-07-31
00850035498415Progen PRP EclipseF5PG0172022-04-22
00850035498422Progen PRP EclipseF5PG0182022-04-22
00850035498439Progen PRP EclipseF5PG0192022-04-22
00850035498446Progen PRP EclipseF5PG0202022-04-22
10863221000320SkinPen Precision Treatment Kits1F5SP0182018-04-09

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