FDA.reportPublic FDA data

Hair growth laser device

Definition
An electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting.
GUDID devices
124
Last updated
2026-08-08 10:08:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05061091983134Beauty PieLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDT-119-HRC2026-06-23
09361725024414Bon ChargeLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDT-119-HRC-BC2025-11-28
06974958310587ideatherapyShenzhen Idea Light LimitedILC-144AxB112026-07-09
06977638360483Hair Growth DeviceDongguan Boyuan Intelligent Technology Co.,LtdKCA451-200S2026-07-09
06977638360612Hair Growth DeviceDongguan Boyuan Intelligent Technology Co.,LtdKCA441-200S2026-07-09
00731093153129CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdMZ-07M2026-06-27
00850079561014CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdZLD-72B2026-06-27
00860011935582CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdMZ-07AM2026-06-27
00860011935599CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdMZ-07AL2026-06-27
06970006973285CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdMZ-07L2026-06-27
00810045460901CapillusCAPILLUS, LLCOne2022-12-29
00810045460918CapillusCAPILLUS, LLCPlus S12022-12-29
00810045460956CapillusCAPILLUS, LLCFocal Temple2022-12-29
00810045460963CapillusCAPILLUS, LLCFocal Crown2022-12-29
00810045460970CapillusCAPILLUS, LLCFocal Medial2022-12-29
00810045461007CapillusCAPILLUS, LLCPro S12022-12-29
00810045461014CapillusCAPILLUS, LLCOne S2022-12-29
00840223305984HAIRCLUB RX™Xtrallux, LLCHairClub RX™ Advanced2026-03-30
00840223305991HAIRCLUB RX™Xtrallux, LLCHairClub RX™ Premium2026-03-30
00840223306004HAIRCLUB RX™Xtrallux, LLCHairClub RX™ Elite2026-03-30
00850003374178LOCKrx Red Light CapRevian, Inc.10000-100152026-05-18
00850056575157HairStem LaserCapLaserCap Company008500565751572026-05-01
00851234001048RedRestore10589578 Canada Inc.812021-05-28
00853327006411CapillusCAPILLUS, LLCRx2022-12-29
00853327006527CapillusCAPILLUS, LLCultra2022-12-29
00853327006534CapillusCAPILLUS, LLCultra XL2022-12-29
00853327006541CapillusCAPILLUS, LLCplus XL2022-12-29
00853327006558CapillusCAPILLUS, LLCplus2022-12-29
00853327006565CapillusCAPILLUS, LLCPro2022-12-29
00853327006572CapillusCAPILLUS, LLCPro XL2022-12-28
00853327006671CapillusCAPILLUS, LLCOfficePro 3522022-12-29
00859690003675iRestoreFREEDOM LASER THERAPY, INC.ID-5052019-07-09
00859690003910iRestoreRemax Medi-Tech (Shenzhen) CorporationID-5102023-08-01
00860007783470Xtrallux™Xtrallux, LLCXtrallux™ Advanced2026-04-02
00860007783487Xtrallux™Xtrallux, LLCXtrallux™ Premium2026-04-02
00860007783494Xtrallux™ Xtrallux, LLCXtrallux™ Elite 2026-04-02
00861134000102iGrow Hair Growth SystemAPIRA SCIENCE, INC.PE104IG002017-12-28
06953808300503Laser CapHubei YJT Intelligent Technology Group Co., Ltd.Hat-012026-04-29
06953808300510Laser Therapy Hair Growth CombHubei YJT Intelligent Technology Group Co., Ltd.Lasercomb-0012026-04-29
06953808300527Laser Therapy Hair Growth CombHubei YJT Intelligent Technology Group Co., Ltd.Lasercomb-0022026-04-29
06974958310457LIFEPRO FITNESSShenzhen Idea Light LimitedLP-RJVGRW-BLK2026-04-17
G680TW147Laser Hair Growth CapBLISSCO MEDICAL DEVICE LIMITED1.02024-12-16
00810045461571CapillusCAPILLUS, LLCTri Spectrum2026-03-01
07899995243669BioHorizonsSin Sistema de Implante Nacional S/ADZD42L2025-11-25
00810045461533CapillusCAPILLUS, LLCMD Duo2025-09-03
00810045461564CapillusCAPILLUS, LLCRx Duo2025-09-03
00810045461526CapillusCAPILLUS, LLCPro S22025-08-19
00860007783456Xtrallux™Xtrallux, LLCLaser Comb Alpha2025-07-01
00850049532440HIGHERDOSEShenzhen Kaiyan Medical Equipment Co,. LtdHG-120K2025-06-28
00850062024557EXOCEUTICALSShenzhen Kaiyan Medical Equipment Co,. LtdSZ-22A2025-06-28
06970006970918NOOANCEShenzhen Kaiyan Medical Equipment Co,. LtdM-2822025-06-28
06970006970925NOOANCEShenzhen Kaiyan Medical Equipment Co,. LtdM-1202025-06-28
06978743639853Diode Laser CapCosmo Far East Technology LimitedCOSMO-3022025-06-26
00850003374161GetHairMDRevian, Inc.10000-100132025-05-07
06975488665482BreoShenzhen Breo Technology Co., Ltd.Scalp 3L2025-01-14
06975488664256BreoShenzhen Breo Technology Co., Ltd.N/A2024-12-25
00810045461458CapillusCAPILLUS, LLCSpectrum MD2024-12-19
07640260120297FAQ 302Foreo ABBlack Diamond2024-12-19
G680D549215GWODE Laser Hair Growth CapBLISSCO MEDICAL DEVICE LIMITED1.02024-11-16
00850003374017Revian Inc. Replacement Kit, 120V AC-5V DC, 2A Wall, Type A PlugRevian, Inc.10000-127072024-11-19
00850003374147Revian Inc. Replacement Kit USB-C Power CableRevian, Inc.10000-127232024-11-19
00862712000392Revian LyteRevian, Inc.10000-100112024-11-19
D549215GWODE Laser Hair Growth CapBLISSCO MEDICAL DEVICE LIMITED1.02024-11-16
00810045461410CapillusCAPILLUS, LLCSpectrum2024-10-16
00850001456708RevvOmm Imports Inc.E550R2024-08-28
008500033741162M USB Magnetic Cable v2 Only Replacement KitRevian, Inc.10000-127202024-08-02
00850003374093Revian Magnetic Micro-USB Connector Only Replacement KitRevian, Inc.10000-127182024-04-06
00850003374109Revian 2M USB to Magnetic MicroUSB Cable Only Replacement KitRevian, Inc.10000-127192024-04-06
00850003374130Revian 2M USB to Magnetic Cable & Insert v2 Replacement KitRevian, Inc.10000-127222024-04-06
00862712000316Revian AC Adaptor Replacement KitRevian, Inc.10000-124002024-04-06
00862712000378REVIAN Headliner Universal KitRevian, Inc.10000-126002024-04-06
00731093153136CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdMZ-072024-01-30
00856823006305Actonis,HairmaxLexington International, LLCHXXXYY2023-12-05
00860007783401Xtrallux™Xtrallux, LLCXtrallux™ Alpha2023-11-17
00860007783418Xtrallux™Xtrallux, LLCXtrallux™ Super Plus Reg Size 2023-11-17
00860007783425Xtrallux™Xtrallux, LLCXtrallux™ Super Plus2023-11-17
00860007783432Xtrallux™Xtrallux, LLCXtrallux™ Turbo Pro 2023-11-17
00860007783449Xtrallux™Xtrallux, LLCXtrallux™ Extreme RX2023-11-17
00850056575003LaserCap HD+LaserCap Company008500565750032023-09-08
00850056575010LaserCap HDLaserCap Company008500565750102023-09-08