FDA.reportPublic FDA data

Red-light phototherapy unit, professional

Definition
An 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.
GUDID devices
43
Last updated
2026-07-17 21:58:44

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08800291820323HEALITE IICynosure Lutronic Technology CorporationHEALITE II(830nm)_110V2026-06-23
08800077100045SMARTLUX MINIMedmix Co., Ltd.D4780002022-07-25
00199874241616MuReva OM™MuReva Phototherapy Inc.10001552026-06-08
00199874868073MuReva OM™MuReva Phototherapy Inc.10003002026-06-08
00199874891422MuReva OM™MuReva Phototherapy Inc.10003292026-06-08
00199874947471MuReva OM™MuReva Phototherapy Inc.10003072026-06-08
05060494130664NIR Acutip LaserTHOR PHOTOMEDICINE LIMITED32026-05-07
05060494130671Trigger Point LaserTHOR PHOTOMEDICINE LIMITED32026-05-07
05060494130688Red Acutip LaserTHOR PHOTOMEDICINE LIMITED32026-05-07
05060494130695Red LaserTHOR PHOTOMEDICINE LIMITED22026-05-07
05060494130701Laser ClusterTHOR PHOTOMEDICINE LIMITED22026-05-07
05060494130718Giant Laser ClusterTHOR PHOTOMEDICINE LIMITED32026-05-07
05060494130725Large LED ClusterTHOR PHOTOMEDICINE LIMITED32026-05-07
05060494130732Medium LED ClusterTHOR PHOTOMEDICINE LIMITED32026-05-07
05060494130749Small LED ClusterTHOR PHOTOMEDICINE LIMITED32026-05-07
05060494130756Trigger Point HandpieceTHOR PHOTOMEDICINE LIMITED22026-05-07
08809447651675N/ALutronic Corporation830&590nm Head2016-09-09
08809447651699Healite IILutronic CorporationHealite Body Assy2016-09-09
08809447651729N/ALutronic CorporationArm2016-09-09
96979303250276CuteleafZhangzhou Win Share Co.,Ltd.V1.02026-01-12
96979303250283CuteleafZhangzhou Win Share Co.,Ltd.V1.02026-01-12
B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDEMVITAL2025-11-19
B749200002010Valeda Light Delivery SystemLUMITHERA, INC.200002-012024-12-16
91201180900032OrthoPulseBiolux Technology GmbHOrthoPulse Lite2026-03-11
06979292890009SummusLasxbot (Shenzhen) Robot Co., LtdSLP-H00012026-02-27
0506049413063369 LED Cluster issue 3THOR PHOTOMEDICINE LIMITED32025-07-31
0506049413064019 LED Cluster issue 3THOR PHOTOMEDICINE LIMITED32025-07-31
05060494130657104 LED Cluster issue 3THOR PHOTOMEDICINE LIMITED32025-07-31
05060494130619810nm 200mW NIR Light Guide LaserTHOR PHOTOMEDICINE LIMITED2.02025-07-15
05060494130626660nm 75mW Red Light Guide LaserTHOR PHOTOMEDICINE LIMITED1.02025-07-15
B271MCUIH0Main Controller Unit I Home (MCU I-H)Meditech International IncMCU I-H2025-06-26
B271MCUIP0Main Controller Unit I Professional (MCU I-P)Meditech International IncMCU I-P2025-06-26
B108043PO30WMUS00LS-6000BTL INDUSTRIES LIMITEDLS-60002024-03-22
00850056256407Collagentex Series Tanses Technologies IncRX-12023-10-16
00850056256414Collagentex Series Tanses Technologies IncRX-1-Seat2023-10-16
00850056256421Collagentex Series Tanses Technologies IncRx-22023-10-16
00850056256438Collagentex Series Tanses Technologies IncRx-32023-10-16
00850056256445Collagentex Series Tanses Technologies IncRx-62023-10-16
B271MCUI0MiniPort Main Controller UnitMeditech International IncMCU I2023-10-02
B271ART1800SLD+ 180AMeditech International IncSLD+ 180A2023-09-18
B271CUPA0Controller Unit (CU+A)Meditech International IncCU+A2023-09-18
09120118090074OrthoPulseBiolux Technology GmbHOrthoPulse 2.0 Extended2023-08-29
05060981240005KINEONShenzhen Kaiyan Medical Equipment Co,. LtdXG-01B2023-07-26