FDA.reportPublic FDA data

Tri-Beam Nd:YAG Laser System

Primary DI
08800020102010
Brand
Tri-Beam Nd:YAG Laser System
Company
Jeisys Medical Inc.
Model
TRI-BEAM
Device description
POWERED LASER SURGICAL INSTRUMENT
Published
2016-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K122922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122922000E-BEAM ND: YAG LASEREclipse Aesthetics, LLC2013-01-10GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
8800020102034PackageGS11In Commercial Distribution
08800020102010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
8800020102034088000201020348800020102034
08800020102010088000201020108800020102010

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological frequency-doubled solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690275362
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020108333DENSITY TipClassic-B Tip2026-03-16
08800020108340DENSITY TipClassic-E Tip2026-03-16
08800020108357DENSITY TipClassic-F Tip2026-03-16
08800020108364DENSITY TipHigh-B Tip2026-03-16
08800020108371DENSITY TipHigh-E Tip2026-03-16
08800020108388DENSITY TipHigh-F Tip2026-03-16
08800020101525POTENZANeutral Electrode Pad Cable2026-03-16
08800020108166DENSITYFoot switch2026-03-16
08800020108173DENSITYPower cord2026-03-16
08800020108180DENSITYNeutral Electrode Pad cable2026-03-16
08800020108197DENSITYHandpiece holder2026-03-16
08800020108203DENSITYHandpiece cradle2026-03-16
08800020108289DENSITY TipClassic-B Tip2026-03-16
08800020108272DENSITY TipClassic-E Tip2026-03-16
08800020108296DENSITY TipClassic-F Tip2026-03-16
08800020108302DENSITY TipHigh-B Tip2026-03-16
08800020108319DENSITY TipHigh-E Tip2026-03-16
08800020108326DENSITY TipHigh-F Tip2026-03-16
08800020108395POTENZAFoot Switch2026-03-16
08800020108401POTENZAPower Cable2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14