FDA.reportPublic FDA data

SkinPen Precision Elite

Primary DI
00850060751028
Brand
SkinPen Precision Elite
Company
Bellus Medical, LLC
Model
REF015
Catalog number
F5SP388
Device description
SPP Elite Microneedling Cartridge
Published
2024-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K241400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241400000SkinPen Precision Elite SystemCrown Aesthetics2024-08-29QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850060751066PackageGS124In Commercial Distribution
00850060751073PackageGS11In Commercial Distribution
00850060751080PackageGS124In Commercial Distribution
00850060751097PackageGS112In Commercial Distribution
00850060751189PackageGS11In Commercial Distribution
00850060751288PackageGS112In Commercial Distribution
00850060751301PackageGS112In Commercial Distribution
00850060751745PackageGS11In Commercial Distribution
00850060751752PackageGS112In Commercial Distribution
00850060751776PackageGS124In Commercial Distribution
00850060751851PackageGS11In Commercial Distribution
00850060751868PackageGS112In Commercial Distribution
00850060751875PackageGS124In Commercial Distribution
00850060751899PackageGS11In Commercial Distribution
00850060751028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850060751066008500607510668500607510660850060751066
00850060751073008500607510738500607510730850060751073
00850060751080008500607510808500607510800850060751080
00850060751097008500607510978500607510970850060751097
00850060751189008500607511898500607511890850060751189
00850060751288008500607512888500607512880850060751288
00850060751301008500607513018500607513010850060751301
00850060751745008500607517458500607517450850060751745
00850060751752008500607517528500607517520850060751752
00850060751776008500607517768500607517760850060751776
00850060751851008500607518518500607518510850060751851
00850060751868008500607518688500607518680850060751868
00850060751875008500607518758500607518750850060751875
00850060751899008500607518998500607518990850060751899
00850060751028008500607510288500607510280850060751028

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.

Contacts#

Phone, Email table
PhoneEmail
1-888-372-3982customerservice@crownaesthetics.com

Regulatory Flags#

DUNS number
005677967
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00850035498279SP MicroPen EVO Microneedling CartridgeF5SP2232022-05-25
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
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
08800118100348NAWoorhi Mechatronics Co., Ltd.QAI2026-09-04
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
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
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMHydrafacial LLCQAI2026-03-27
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