FDA.reportPublic FDA data

Veincare

Primary DI
08800022301404
Brand
Veincare
Company
WONTECH CO.,LTD
Model
Veincare
Device description
Surgical Diode Laser System
Published
2024-12-17
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241930000
K251288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241930000VeincareWontech Co., Ltd.2024-11-14GEX
K251288000VeincareWontech Co., Ltd.2025-05-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800022301404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800022301404088000223014048800022301404

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695658263
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800022304108SANDRO DualSANDRO Dual2020-06-16
08800022304412PICOALEXPICOALEX2025-03-25
08800022300803PastellePastelle2017-08-16
08800022304405PicowonPicowon2020-10-06
08800022300209Cosjet SRCosjet SR2017-08-16
08800022305327Oligio XOligio X2024-03-21
08800022305310The OligioThe Oligio2023-02-17
08800022304016ALMA VEIL; V-LaserALMA VEIL; V-Laser2023-08-24
08800022301800WONTECH Surgical Optic FibersBA4002025-02-24
08800022301817WONTECH Surgical Optic FibersBA6002025-02-24
08800022301824WONTECH Surgical Optic FibersBA400R2025-02-24
08800022301831WONTECH Surgical Optic FibersBA600R2025-02-24
08800022302906Pastelle ProPastelle Pro2025-02-24
08800022301121NOUVADermNOUVADerm2024-10-04
08800022301107LavieenLavieen2023-09-20
08800022305600PICOCAREMAJESTYPICOCAREMAJESTY2022-02-01
08800022305914PICOANDYPICOANDY2024-03-21
08800022304009V-LaserV-Laser2019-05-21
08800022304924Hair Boom69, Hair Beam Air, Hair Boom, Hair Boom Air, Ulike Hair UpUpHair Boom69, Hair Beam Air, Hair Boom, Hair Boom A2019-10-28
08800022303620Air Gap FiberAG2752024-02-05

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Primary DI, Brand, Company table
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00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16