FDA.reportPublic FDA data

SKINSTYLUS STERILOCK 36-PIN CARTRIDGE IN POUCH

Primary DI
00810007534947
Brand
SKINSTYLUS STERILOCK 36-PIN CARTRIDGE IN POUCH
Company
Hydrafacial LLC
Model
10446
Catalog number
10446
Device description
SKINSTYLUS STERILOCK 36-PIN CARTRIDGE IN POUCH
Published
2026-08-19
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
K200044000
K231073000
K253002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200044000SkinStylus SteriLock MicroSystemEsthetic Education, LLC2020-04-10QAI
K231073000SkinStylus SteriLock® MicroSystem, Model Number MP1209SLEsthetic Medical, Inc.2023-07-28QAI
K253002000SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.2026-02-19QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007534947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007534947008100075349478100075349470810007534947

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
8006034996regulatory@hydrafacial.com

Regulatory Flags#

DUNS number
364134791
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
00810007534930SKINSTYLUS STERILOCK 12-PIN CARTRIDGE IN POUCH10445104452026-08-19
00810007534954SKINSTYLUS STERILOCK HILO CARTRIDGE IN POUCHSL38679SL386792026-08-19
00810007533643Hydrafacial™ Syndeo™ BLACK 240V KOREA240V Black, Non Medical2026-03-27
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMSKINSTYLUS STERILOCK MICROSYSTEM2026-03-27
00850043007371Del Sol Blue Light Therapy SystemCordless (EU)70392-012017-07-03
00810007534794Hydrafacial™ Elite System, 240V INTERNATIONAL240V Black, Non Medical70290-03-01-ITL2026-03-13
00810007534756Hydrafacial™ Lip TipHydrafacial™ Lip Tip2025-07-16
00810007534763HydraScalp™ Tip, Purify, 6-PackHydraScalp™ Tip, Purify, 6-Pack2025-07-16
00810007534770HydraScalp™ Tip, Nourish, 6-PackHydraScalp™ Tip, Nourish, 6-Pack2025-07-16
00810007532394Hydrafacial Syndeo120V, Black7000078-BLK2024-07-11
00810007531311Hydrafacial MD Elite240V70290-03-012024-07-18
00810007531540Hydrafacial MD Elite120V70143-03-012024-07-18
00810007531595Hydrafacial MD Allegro120V704152024-07-18
00810007532400Hydrafacial Syndeo240V Black7000079-BLK2024-07-18
00810007532479Hydrafacial Syndeo120V, White7000078-WHT2024-07-18
00810007532486Hydrafacial Syndeo240V White7000079-WHT2024-07-18
00810007532493Hydrafacial Syndeo240V White No-Perk7000079-WHT-NPK2024-07-18
00810007532509Hydrafacial Syndeo120V, White No Perk7000078-WHT-NPK2024-07-18
00810007532516Hydrafacial Syndeo240V Black No Perk7000079-BLK-NPK2024-07-18
00810007532523Hydrafacial Syndeo120V, Black No Perk7000078-BLK-NPK2024-07-18

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
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
04260446131065XCELLARISPRO TWIST microneedling deviceDermaroller GmbHQAI2025-08-26