FDA.reportPublic FDA data

Red-light phototherapy unit, line-powered

Definition
A mains electricity (AC-powered) device designed to emit a low-level narrow-band (LLNB) red light in the visible and invisible wavelength around 600-940 nm, with the intent to modify cellular metabolism and/or improve blood flow through increased vasodilation primarily for the accelerated healing of cutaneous or mucosal wounds and/or to provide pain relief. It can be used in a healthcare facility and in the home. It may be used to help treat skin ulcers, acne, herpes simplex lesions, and postoperative wounds, or to relieve pain associated with inflammatory processes such as rheumatoid arthritis (RA) or lower back injury.
GUDID devices
79
Last updated
2021-07-26 22:42:13

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08809447651712N/ALutronic CorporationManual2016-09-09
08809447652122N/ALutronic CorporationGoggle ASSY (For patient)2018-08-06
8809447651682N/ALutronic Corporation830&590nm Head2016-09-09
8809447651705Healite IILutronic CorporationHealite Body Assy2016-09-09
8809447651736N/ALutronic CorporationArm2016-09-09
09120118090029OrthoPulseBiolux Technology GmbHOPi2021-06-30
04719873240029Applied BioPhotonics Phototherapy SystemAPPLIED BIOPHOTONICS LIMITEDABPT1003-22021-06-08
05060494130541Lollipop ProbeTHOR PHOTOMEDICINE LIMITED2.32021-05-17
05060494130558810nm 16W Cluster PRX100 (80x200mW)THOR PHOTOMEDICINE LIMITED2.32021-05-17
05060494130565PRX Lollipop ProbeTHOR PHOTOMEDICINE LIMITED2.32021-05-17
05060494130503NovoTHORTHOR PHOTOMEDICINE LIMITED3.02021-01-08
05060494130510NovoTHOR XLTHOR PHOTOMEDICINE LIMITED3.02021-01-08
05060494130527NovoTHOR PRXTHOR PHOTOMEDICINE LIMITED3.02021-01-08
05060494130534NovoTHOR XL PRXTHOR PHOTOMEDICINE LIMITED3.02021-01-08
05060494130459810nm 16W (80x200mW) - Giant Laser ClusterTHOR PHOTOMEDICINE LIMITED2.32020-08-12
05060494130466NovoTHOR Gen 3.0 RegTHOR PHOTOMEDICINE LIMITED3.02020-08-12
05060494130473NovoTHOR Gen 3.0 XLTHOR PHOTOMEDICINE LIMITED3.02020-08-12
05060494130480NovoTHOR Gen 3.0 Reg PRXTHOR PHOTOMEDICINE LIMITED3.02020-08-12
05060494130497NovoTHOR Gen 3.0 XL PRXTHOR PHOTOMEDICINE LIMITED3.02020-08-12
0506049413037469 LED Clust Probe PRX100 660nm & 850nm 1390mWTHOR PHOTOMEDICINE LIMITED2.32019-10-03
05060494130381104 LED Cluster Probe PRX100 660nm & 850nmTHOR PHOTOMEDICINE LIMITED2.32019-10-03
05060494130398810nm 200mW Acu Tip PRX100 B/GTHOR PHOTOMEDICINE LIMITED2.32019-10-03
05060494130404810nm 200mW Dental Probe PRX100THOR PHOTOMEDICINE LIMITED2.32019-10-03
05060494130411810nm 200mW Standard Tip - PRX100THOR PHOTOMEDICINE LIMITED2.32019-10-03
05060494130428660nm 75mW Dental Probe PRX100THOR PHOTOMEDICINE LIMITED2.32019-10-03
05060494130435810nm 1W Cluster (5x200mW) PRX100THOR PHOTOMEDICINE LIMITED2.32019-10-03
05060494130442660nm 75mW Dental Probe LiTEFORM PRXTHOR PHOTOMEDICINE LIMITED2.32019-10-03
B271CU0Controller Unit (CU)Meditech International IncCU2016-08-09
B271CUP0Controller Unit (CU+)Meditech International IncCU+2016-08-09
B271DUO1800DUO+ 180 (LS-B 2250)Meditech International IncLS-B 22502016-08-09
B271DUO2400DUO+ 240 (LS-B 3000)Meditech International IncLS-B 30002016-08-09
B271LDI2000LD-I 200Meditech International IncLD-I 2002016-08-09
B271LDI200P0LD-I 200+Meditech International IncLD-I 200+2018-02-01
B271LDR1000LD-R 100Meditech International IncLD-R 1002016-08-09
B271LDR100P0LD-R 100+Meditech International IncLD-R 100+2018-02-01
B271LSB2250P0DUO+ 180 (LS-B 2250+)Meditech International IncLS-B 2250+2018-02-01
B271LSB3000P0DUO+ 240 (LS-B 3000+)Meditech International IncLS-B 3000+2018-02-01
B271LSB32700DUOFLEX+ 120 (LS-B 3270)Meditech International IncLS-B 32702018-02-01
B271LSB48900DUOFLEX+ 180 (LS-B 4890)Meditech International IncLS-B 48902018-02-01
B271MCU0Main Controller Unit (MCU)Meditech International IncMCU2016-08-09
B271MCUIII0Main Controller Unit III (MCU III)Meditech International IncMCU III2018-02-01
B271MCUIV0Main Controller Unit IV (MCU IV)Meditech International IncMCU IV2018-02-01
B271SLD1200SLD+ 120Meditech International IncSLD+ 1202016-08-09
B271SLD1800SLD+ 180Meditech International IncSLD+ 1802016-08-09
04719873240012Applied BioPhotonics Phototherapy SystemAPPLIED BIOPHOTONICS LIMITEDABPT10032016-09-23
05060494130008104 LED Cluster Probe 660nm & 850nm 2WTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130015104 LED Cluster Probe 660nm & 850nm 2WTHOR PHOTOMEDICINE LIMITED2.32016-09-20
0506049413002219 LED Cluster Probe 660nm & 850nm 370mWTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130039660nm 100mW Acu Tip B/GTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130046660nm 200mW Acu Tip B/GTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130053660nm 200mW Standard Tip B/GTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130060660nm 30mW Acu Tip B/GTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130077660nm 30mW Acu Tip B/GTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130084660nm 30mW Standard Tip B/GTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130091660nm 30mW Standard Tip B/GTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130107660nm 75mW Dental ProbeTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130114660nm 75mW Dental ProbeTHOR PHOTOMEDICINE LIMITED2.32016-09-20
0506049413012169 LED Cluster Probe 660nm & 850nm 1390mWTHOR PHOTOMEDICINE LIMITED2.02016-09-20
0506049413013869 LED Cluster Probe Wavelength = 660nm & 850nm PowerTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130145810nm 1W Cluster (5x200mW)THOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130176810nm 200mW Acu Tip B/GTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130183810nm 200mW Acu Tip B/GTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130190810nm 200mW Dental ProbeTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130206810nm 200mW Dental ProbeTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130213810nm 200mW Standard TipTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130220810nm 200mW Standard TipTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130237810nm 2W Cluster (5x400mW)THOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130244810nm 2W Cluster (5x400mW)THOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130251810nm 2W Cluster C (5x400mW)THOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130268810nm 450mW Acu Tip B/GTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130275810nm 450mW Acu Tip B/GTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130282810nm 450mW Dental ProbeTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130299810nm 450mW Standard Tip B/GTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130305810nm 450mW Standard Tip B/GTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130312Skin Conduction ProbeTHOR PHOTOMEDICINE LIMITED2.32016-09-20
05060494130329LX2 M Control UnitTHOR PHOTOMEDICINE LIMITED2.02016-09-20
05060494130336LX2 2.3 Control UnitTHOR PHOTOMEDICINE LIMITED2.032016-09-20
05060494130343BrainTHORTHOR PHOTOMEDICINE LIMITED12018-12-13
00815950000013OrthoPulseBiolux Research LimitedOPi2016-08-23