FDA.reportPublic FDA data

Accu-Beam

Primary DI
B17791852BDW0
Brand
Accu-Beam
Company
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Model
9185-2B-DW
Device description
Re-usable fiberoptic handpiece for lasers.340mm, 20 degree bend, double wall.
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K952006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952006000ACCU-BEAM FIBER OPTIC HANDPIECETti Medical1995-05-31GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B17791852BDW0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9255537828info@ttimedical.com

Regulatory Flags#

DUNS number
130213366
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1779450F0Accu-Surg9450F2026-04-21
B177700500180Accu-Beam700500182026-04-14
B177950134700Accu-Beam9501-34/702022-02-23
B177950150700Accu-Beam9501-50/702020-06-30
B17781860Accu-Beam81862020-05-19
B17731260532L0Accu-Beam31260-532L2025-07-23
B17731260532Z0Accu-Beam31260-532Z2025-07-23
B17731260455L0Accu-Beam31260-455L2025-07-21
B17731260455Z0Accu-Beam31260-455Z2025-07-21
B177301650T5320Accu-Beam301650T-5322021-11-19
B1773122602B0Accu-Beam31226-02B 2021-06-25
B1773126002B0Accu-Beam31260-02B 2021-06-25
B1778194101M0Accu-Beam8194101M2019-05-30
B1778194101M010Accu-Beam8194101M-012019-05-30
B1772000029800Accu-Beam2000029802019-01-25
B1772000039490Accu-Beam2000039492019-01-15
B1772010TTI0Accu-Beam2010TTI2018-07-25
B17725045120Accu-Beam25045122018-08-27
B17725045130Accu-Beam25045132018-08-27
B1772570160010Accu-Beam2570160012018-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173391882Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391912Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391196Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2020-06-09
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390786Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
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