FDA.reportPublic FDA data

SkinPen Precision Premium Treatment Kit

Primary DI
00850035498873
Brand
SkinPen Precision Premium Treatment Kit
Company
Bellus Medical, LLC
Model
F5SP391
Catalog number
F5SP391
Device description
Treatment kit which includes a sterile, disposable cartridge tip, a hydrogel, and a disposable sleeve.
Published
2023-07-31
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850035498873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035498873008500354988738500354988730850035498873

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. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888.372.3982customerservice@crownaesthetics.com

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
00850035498279SP MicroPen EVO Microneedling CartridgeF5SP2232022-05-25
00850060751028SkinPen Precision EliteREF015F5SP3882024-10-01
00850060751738SkinPenF5SP5812026-05-20
00863221000309SkinPen Precision CartridgeREF014F5SP0212018-04-09
00850060751110ProGen PRP EclipseP5PG052PROGEN-A152024-08-28
00850060751158ProGen PRP EclipseP5PG053PROGEN-A302024-08-28
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
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
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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
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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
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMHydrafacial LLCQAI2026-03-27
00860015460646LuxPen Microneedling CartridgesT AESTHETICS LLCQAI2026-03-20
00860015460608LuxPenT AESTHETICS LLCQAI2026-03-12
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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
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