FDA.reportPublic FDA data

Accu-Beam

Primary DI
B17770080
Brand
Accu-Beam
Company
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Model
7008
Device description
Easy Spot micromanipulator for articulated arm CO2 lasers.
Published
2016-07-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B17770080PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
B17731260532L0Accu-Beam31260-532L2025-07-23
B17731260532Z0Accu-Beam31260-532Z2025-07-23
B17731260455L0Accu-Beam31260-455L2025-07-21
B17731260455Z0Accu-Beam31260-455Z2025-07-21
B1773122602B0Accu-Beam31226-02B2021-06-25
B1773126002B0Accu-Beam31260-02B2021-06-25
B17704342043D0Accu-Beam04342043D2017-10-26
B17704342044C0Accu-Beam04342044C2017-10-26
B1779450F0Accu-Surg9450F2026-04-21
B177950134700Accu-Beam9501-34/702022-02-23
B177950150700Accu-Beam9501-50/702020-06-30
B177700500180Accu-Beam700500182026-04-14
B17791852BDW0Accu-Beam9185-2B-DW2026-03-30
B17781860Accu-Beam81862020-05-19
B177301650T5320Accu-Beam301650T-5322021-11-19
B1778194101M0Accu-Beam8194101M2019-05-30
B1778194101M010Accu-Beam8194101M-012019-05-30
B1772000029800Accu-Beam2000029802019-01-25
B1772000039490Accu-Beam2000039492019-01-15
B1772010TTI0Accu-Beam2010TTI2018-07-25

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
B1777021580Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALHHR2024-01-09
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