FDA.reportPublic FDA data

Red/infrared light phototherapy unit

Definition
An electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.
GUDID devices
263
Last updated
2026-10-04 01:48:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850061407221LS Pro SystemsWELLNESS WITHOUT LIMITS LLCLS-ZLD-DLT012026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.QLXY-012026-09-24
06974958310594mitoredlightShenzhen Idea Light LimitedMitoADAPT MIN 4.02026-09-21
06974958310617mitoredlightShenzhen Idea Light LimitedMitoADAPT MAX 4.02026-09-21
06974958310624mitoredlightShenzhen Idea Light LimitedMitoQUAD Belt2026-09-21
00860009854598OvationULTBody Balance System, LLCSST (SGS)2025-10-30
00810025926953Caring MillLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDCM-ZLD-602024-03-16
00810025926960Caring MillLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDCM-ZLD-60-BP2024-03-16
00810025926977Caring MillLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDCM-ZLD-60-NW2024-03-16
00843041125826Tommie CopperLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDTC-ZLD-60V-BW2025-02-15
00843041125833Tommie CopperLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDTC-HX-60B-JW2025-02-15
00843041125840Tommie CopperLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDTC-ZLD-46-NP2025-02-15
00843041125857Tommie CopperLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDTC-ZLD-60-X-SW2025-02-15
00843041143172Tommie CopperLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDTC-ST-58-HM2025-02-15
00850026680218Aura WellnessAura Wellness, LLCROC2026-07-21
00860009854529OvationBody Balance System, LLCULT2023-09-18
00860009854536OvationULTBody Balance System, LLCSST2024-06-21
00031262108494HOMEDICSFKA DISTRIBUTING CO., LLCIFR-100HJ-22023-05-26
06973337180018Led Light Phototherapy BedShenzhen Suyzeko LimitedGY-680A 2026-05-09
06973337180025Led Light Phototherapy BedShenzhen Suyzeko LimitedPro4502026-05-09
06974958310136IdeainfraredShenzhen Idea Light LimitedTLB1052023-07-27
06974958310143IdeainfraredShenzhen Idea Light LimitedTLB1202023-07-27
06974958310150 IdeainfraredShenzhen Idea Light LimitedTLB3002023-07-27
06974958310167NAShenzhen Idea Light LimitedRL05C2023-07-27
06975188960016ZONNZonnsmart Science & Technology Co.,LtdHL8002024-08-27
06975188960023ZONNZonnsmart Science & Technology Co.,LtdHL800-BT 2024-08-27
06975188960030ZONNZonnsmart Science & Technology Co.,LtdHL800-MA2024-08-27
06975188960047ZONNZonnsmart Science & Technology Co.,LtdBR012024-08-27
06975188960061ZONNZonnsmart Science & Technology Co.,LtdHL700 PRO 2024-09-10
06975188960078ZONNZonnsmart Science & Technology Co.,LtdHL850 PRO MAX2024-09-10
06975188960085ZONNZonnsmart Science & Technology Co.,LtdHL850 PRO2024-09-10
06975188960092ZONNZonnsmart Science & Technology Co.,LtdHL880 PRO MAX2024-09-10
06975188960108ZONNZonnsmart Science & Technology Co.,LtdHL800 PRO 2024-09-10
06975188960115ZONNZonnsmart Science & Technology Co.,LtdHL811 PRO MAX2024-09-10
06975188960122ZONNZonnsmart Science & Technology Co.,LtdHL811 PRO2024-09-10
06975188960139ZONNZonnsmart Science & Technology Co.,LtdHL711 PRO MAX2024-09-10
06975188960146ZONNZonnsmart Science & Technology Co.,LtdHL711 PRO2024-09-10
G710A480Velara Ascend 48SUNSHINE USA, LLCA482026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCE322026-05-11
G710L240Velara Lounge 24SUNSHINE USA, LLCL242026-05-15
09361725008346BON CHARGELight Tree Ventures Europe B.V.YS-062026-05-25
09361725008360BON CHARGELight Tree Ventures Europe B.V.YS-06A2026-05-25
06977863220149Therapy LightE.SHINE LIGHTING CO., LIMITEDBIOMAXPRO NANO2026-03-02
06977863220156Therapy LightE.SHINE LIGHTING CO., LIMITEDBIOMAXPRO MIDI2026-03-02
06977863220163Therapy LightE.SHINE LIGHTING CO., LIMITEDBIOMAXPRO GRANDE2026-03-02
06977863220170Therapy LightE.SHINE LIGHTING CO., LIMITEDBIOMAXPRO ULTRA2026-03-02
08500723550001SunPowerLEDKERBER USA INC.SuperPalm 10502026-02-26
08500723550018SunPowerLEDKERBER USA INC.Palm Ultimate2026-02-26
08500723550025SunPowerLEDKERBER USA INC.Palm Professional2026-02-26
08500723550049SunPowerLEDKERBER USA INC.Mini-Canopy2026-02-26
08500723550056SunPowerLEDKERBER USA INC.Helmet -8102026-02-26
08500723550063SunPowerLEDKERBER USA INC.Canopy2026-02-26
00840397513284Sharper ImageMerchsource, LLC10193482026-02-17
06956822893013SolawaveShenzhen Goodwind technology development Co.,LtdPH-m032026-02-04
06956822893020SolawaveShenzhen Goodwind technology development Co.,LtdPH-n032026-02-04
06956822893037SolawaveShenzhen Goodwind technology development Co.,LtdPH-e032026-02-04
06979812520034MarrisJjwXiamen Langxing Medical Technology Co., Ltd.RYMRT000032026-01-26
06979322350015N/ADongguan Redthera Technology Co., Ltd.HGHY022026-01-22
06979322350022N/ADongguan Redthera Technology Co., Ltd.RP60002026-01-22
06979322350039N/ADongguan Redthera Technology Co., Ltd.HGSD012026-01-22
06979322350046N/ADongguan Redthera Technology Co., Ltd.R-02-3H2026-01-22
06979322350053N/ADongguan Redthera Technology Co., Ltd.HGTZ012026-01-22
06979322350060N/ADongguan Redthera Technology Co., Ltd.HGHX052026-01-22
06979322350077N/ADongguan Redthera Technology Co., Ltd.HGHB012026-01-22
06979322350084N/ADongguan Redthera Technology Co., Ltd.HGHW012026-01-22
06979322350091N/ADongguan Redthera Technology Co., Ltd.HGST012026-01-22
06979322350107N/ADongguan Redthera Technology Co., Ltd.HGHH012026-01-22
06979322350114N/ADongguan Redthera Technology Co., Ltd.HGHJ022026-01-22
06979344920197AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LTP-092026-01-14
06979344920203AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LTP-102026-01-14
06979344920210AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP012026-01-14
06979344920227AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP022026-01-14
06979344920234AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP032026-01-14
06979344920241AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP042026-01-14
06979344920258AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP052026-01-14
06979344920265AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP062026-01-14
06979344920272AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP072026-01-14
06979344920289AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP082026-01-14
06979344920296AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP092026-01-14
06979344920302AisQueenShenzhen Ais Queen Medical Technology Co., Ltd.LP102026-01-14