FDA.reportPublic FDA data

Accu-Beam

Primary DI
B1777021580
Brand
Accu-Beam
Company
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Model
7021-58
Device description
Zeiss/CJ Pico Adaptor
Published
2024-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HHRLaser, Surgical, Gynecologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHRLaser, Surgical, GynecologicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864378000CO2 LASER MICROMANIPULATORTransamerican Technologies Intl.1987-03-05HHR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1777021580PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laser adaptorA connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device.

Regulatory Flags#

DUNS number
130213366
Device count
1

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
B17791852BDW0Accu-Beam9185-2B-DW2026-03-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B177700500180Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2026-04-14
B17770700Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2026-02-20
B1771104R0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2025-02-25
B177062537602T0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-08-06
B17770560Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-02-20
B1777021650Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-01-09
B177A55014900TTI0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-01-04
B1771109R0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2022-08-23
17290110122215Tip ClearLift QS 5x5 with Depth Control Set (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122222Tip ClearLift QS 5x5 without Depth Control Set (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122239ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female ALMA LASERS LTD.HHR2021-12-30
17290110122246Tip ClearLift QS CVD (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122253Tip ClearLift QS KTP 532 3mm (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122260Tip ClearLift QS KTP 532 4mm (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122277Tip ClearLift QS Scanner 5x5 & CVD (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122284Tip ClearLift QS 3mm (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122291Tip ClearLift QS 5mm (Female)ALMA LASERS LTD.HHR2021-12-30
17290110122307Tip ClearLift QS 10mm (Female)ALMA LASERS LTD.HHR2021-12-30
B1777065PL0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2021-09-24
B17770580Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2021-04-09
B17770690Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2020-12-02
B1777040ES0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2020-08-31
17290110121942Handpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / ProALMA LASERS LTD.HHR2020-06-24
B17711230Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2019-12-17
B1777065P0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-19
B1773113CAB60Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-18
B1773113OLY50Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-18
B1773113STD510Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-18
B1773113STD60Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-18
B1773113STO750Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2018-12-18