FDA.reportPublic FDA data

VIVACE Microneedle Cartridge

Primary DI
08800017100920
Brand
VIVACE Microneedle Cartridge
Company
shenb Co., Ltd.
Model
SH-TIP
Published
2026-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193070000
K230968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193070000VIVACE Electrosurgical DeviceShenB Co., Ltd.2021-04-26GEI
K230968000VYBE RF Electrosurgical SystemShenB Co., Ltd.2023-07-06GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017100968PackageGS15In Commercial Distribution
08800017100975PackageGS110In Commercial Distribution
08800017100920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017100968088000171009688800017100968
08800017100975088000171009758800017100975
08800017100920088000171009208800017100920

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin surface treatment system applicatorA handpiece component of a radio-frequency skin surface treatment system designed to be used by a healthcare professional to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to the skin in a non-homogenous fractional manner, via an array of multi-electrode pins, to leave minimal-impact areas of skin to facilitate healing. The applicator connects with the system’s control unit and may include vacuum to facilitate its coupling with the skin. This is a reusable device.

Regulatory Flags#

DUNS number
690425442
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
true
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
08800017100616Sterile Micro Needle CartridgeSmart RF 36PIN TIP II2021-12-08
08800017100753Sterile Micro Needle CartridgeExact RF TIP2021-12-08
08800017101002VIVACE PRO, VYBE RF IIVYBE RF II2026-04-22
08800017101422PlaDuo PRO SystemPlaDuo PRO System2025-04-29
08800017101118PlaDuo SystemPlaDuo2023-11-01
08800017100883VYBE RFVYBE RF2022-09-19
08800017100579Sterile Micro Needle CartridgeSmart RF 36PIN TIP2021-12-08
08800017100647Sterile Micro Needle CartridgeDeep RF 36PIN TIP2021-12-08
08800017100678Sterile Micro Needle CartridgeDeep RF 12PIN TIP2021-12-08
08800017100784Sterile Micro Needle CartridgeExact RF TIP II2021-12-08
08800017100821VIRTUE RFVirtueRF2021-12-08
08800017100463VIVACE Electrosurgical SystemVIVACE2021-06-18
08800017100456VirtueRF VirtueRF 2021-03-15
08800017100159PlaDuo SystemPlaDuo2020-12-28
08800017100715Virtue RF Virtue RF 2020-12-10
08800017100722Virtue RF Microneedle CartridgeSmartRF 36PIN TIP2020-12-10
08800017100234VIVACE Microneedle CartridgeSH-TIP2019-10-11
08800017100326VIVACE Electrosurgical SystemVIVACE2019-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433062MillenniumAvalign Technologies, Inc.GEI2026-10-01
10884521740150LigaSureCovidien LPGEI2026-10-01
00190776432980MillenniumAvalign Technologies, Inc.GEI2026-09-30
B382SD070823101310Surgical DirectSurgical Direct, Inc.GEI2026-09-30
10884450452353STAR™Merit Medical Systems, Inc.GEI2026-09-29
00190776432645MillenniumAvalign Technologies, Inc.GEI2026-09-28
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21