FDA.reportPublic FDA data

Collagentex Series

Primary DI
00850056256407
Brand
Collagentex Series
Company
Tanses Technologies Inc
Model
RX-1
Device description
Rx-1 NIR device, model Rx-1, 1 lamp module
Published
2023-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain TherapyPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162022000Collagentex Rx-1Tanses Technologies, Inc.2016-12-22NHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056256407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056256407008500562564078500562564070850056256407

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, professionalAn electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
450-622-4004info@collagentex.com

Regulatory Flags#

DUNS number
253238190
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056256124Tanses T-32 SeriesTx-32-2002023-10-26
00850056256131Tanses T-32 SeriesTX-32-F2023-10-26
00850056256148Tanses T-32 SeriesTX-32-2F2023-10-26
00850056256155Tanses T-32 SeriesTX-32-3F2023-10-26
00850056256162Tanses T-32 SeriesTX-32-160-F2023-10-26
00850056256179Tanses T-32 SeriesTx-32-160-2F2023-10-26
00850056256186Tanses T-32 SeriesTX-32-160-3F2023-10-26
00850056256193Tanses T-32 SeriesTx-32-200-3F2023-10-26
00850056256254Tanses T-40 SeriesT-402023-10-26
00850056256261Tanses T-40 SeriesT-40-F2023-10-26
00850056256278Tanses T-40 SeriesT-40-3F2023-10-26
00850056256285Tanses T-44 Series Tx-442023-10-26
00850056256292Tanses T-44 SeriesTx-44-3F2023-10-26
00850056256308Tanses T-52 SeriesT-522023-10-26
00850056256315Tanses T-52 SeriesT-52-M2023-10-26
00850056256322Tanses T-52 SeriesT-52-M-F2023-10-26
00850056256339Tanses T-52 SeriesT-52-M-3F2023-10-26
00850056256346Tanses T-72 SeriesT-722023-10-26
00850056256353Tanses T-72 SeriesVector-3F2023-10-26
00850056256018Tanses T-32 SeriesT-32-1602023-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898616351141Therapy US (FDA)DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDANHN2025-12-17
06957510600852LASPOTWuhan Guangdun Technology Co.,Ltd.NHN2025-09-23
16957510600019LASPOTWuhan Guangdun Technology Co.,Ltd.NHN2025-09-23
07898616351127Therapy EC (FDA)DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDANHN2025-01-21
07898616351134Therapy XT (FDA)DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDANHN2025-01-21
00627987397499TheralaseTheralase IncNHN2023-12-14
00627987397475TheralaseTheralase IncNHN2023-10-27
00850056256445Collagentex Series Tanses Technologies IncNHN2023-10-16
00852556007008FibroLuxMulti Radiance MedicalNHN2022-11-08
00858985006278Erchonia GVLERCHONIA CORPORATION, LLCNHN2022-10-31
00858985006193FX405ERCHONIA CORPORATION, LLCNHN2020-08-10
00858985006186FX635ERCHONIA CORPORATION, LLCNHN2020-06-19
00859626006343ML 830®MICROLIGHT CORPORATION OF AMERICANHN2019-04-12
B271LDI200P0LD-I 200+Meditech International IncNHN2018-02-01
00869340000305LaserTouchOneLaser Health Technologies, LLCNHN2017-05-11
00858985006001Base StationERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006025EVLERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006032EVRLERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006049FX635ERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006063PL TouchERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006087VLSERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006094XLR8ERCHONIA CORPORATION, LLCNHN2016-09-24
B420LD1000LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100A0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100B0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100C0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100D0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000PTS0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
00859626006008ML 830®MICROLIGHT CORPORATION OF AMERICANHN2016-08-15
00859626006015ML 830®MICROLIGHT CORPORATION OF AMERICANHN2016-08-15