FDA.reportPublic FDA data

SkinStylus

Primary DI
00196852554485
Brand
SkinStylus
Company
Esthetic Medical Inc
Model
MP1209SL1
Device description
The SkinStylus SteriLock® MicroSystem is a powered microneedling device, intended to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
Published
2023-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K200044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200044000SkinStylus SteriLock MicroSystemEsthetic Education, LLC2020-04-10QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196852554485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196852554485001968525544851968525544850196852554485

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105045262
Device count
1
Serial number
true

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 CartridgesCAMPOMATS 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