FDA.reportPublic FDA data

Therapy US (FDA)

Primary DI
07898616351141
Brand
Therapy US (FDA)
Company
DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
Model
980030035
Catalog number
980030035
Device description
Laser system for therapy
Published
2025-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K252273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252273000Therapy USDmc Importação E Exportação DE Equipamentos Ltda2025-12-12NHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898616351141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898616351141078986163511417898616351141

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, professionalAn electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
904563269
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898616351431OstomyGel2900100032900100032025-04-28
07898616351400e-light I-US2300201482300201482025-03-05
07898616351417e-light B-US2300201492300201492025-03-05
07898616351424e-light V-US 2300201502300201502025-03-05
07898616351127Therapy EC (FDA)9800300329800300322025-01-21
07898616351134Therapy XT (FDA)2300200942300200942025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850056256407Collagentex Series Tanses Technologies IncNHN2023-10-16
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