FDA.reportPublic FDA data

Capillus

Primary DI
00853327006527
Brand
Capillus
Company
CAPILLUS, LLC
Model
ultra
Device description
Cap for hair growth, photobiomodulation. 82 laser diode device with 6 minute treatment time.
Published
2022-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OAPLaser, Comb, Hair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAPLaser, Comb, HairPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853327006527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853327006527008533270065278533270065270853327006527

GMDN Terms#

Term, Definition table
TermDefinition
Hair growth laser deviceAn 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.

Regulatory Flags#

DUNS number
079813345
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810045461571CapillusTri Spectrum2026-03-01
00810045461533CapillusMD Duo2025-09-03
00810045461564CapillusRx Duo2025-09-03
00810045461458CapillusSpectrum MD2024-12-19
00810045461526CapillusPro S22025-08-19
00810045461427CapillusAST-8042025-01-21
00810045461410CapillusSpectrum2024-10-16
00853327006763CapillusX+, HairClub X Plus Laser Cap2023-01-24
00810045461021CapillusMD2023-04-05
00810045460901CapillusOne2022-12-29
00810045460918CapillusPlus S12022-12-29
00810045460956CapillusFocal Temple2022-12-29
00810045460963CapillusFocal Crown2022-12-29
00810045460970CapillusFocal Medial2022-12-29
00810045461007CapillusPro S12022-12-29
00810045461014CapillusOne S2022-12-29
00853327006411CapillusRx2022-12-29
00853327006534Capillusultra XL2022-12-29
00853327006541Capillusplus XL2022-12-29
00853327006558Capillusplus2022-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850003374178LOCKrx Red Light CapRevian, Inc.OAP2026-05-18
00850056575157HairStem LaserCapLaserCap CompanyOAP2026-05-01
06953808300503Laser CapHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-04-29
06953808300510Laser Therapy Hair Growth CombHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-04-29
06953808300527Laser Therapy Hair Growth CombHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-04-29
06974958310457LIFEPRO FITNESSShenzhen Idea Light LimitedOAP2026-04-17
00850523007365CellumaBiophotas, Inc.OAP2026-04-06
00860007783470Xtrallux™Xtrallux, LLCOAP2026-04-02
00860007783487Xtrallux™Xtrallux, LLCOAP2026-04-02
00860007783494Xtrallux™ Xtrallux, LLCOAP2026-04-02
00840223305984HAIRCLUB RX™Xtrallux, LLCOAP2026-03-30
00840223305991HAIRCLUB RX™Xtrallux, LLCOAP2026-03-30
00840223306004HAIRCLUB RX™Xtrallux, LLCOAP2026-03-30
00810045461571CapillusCAPILLUS, LLCOAP2026-03-01
09361725024414Bon ChargeLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDOAP2025-11-28
00810045461533CapillusCAPILLUS, LLCOAP2025-09-03
00810045461564CapillusCAPILLUS, LLCOAP2025-09-03
00810045461526CapillusCAPILLUS, LLCOAP2025-08-19
00850075326006CellumaBiophotas, Inc.OAP2025-07-24
00860007783456Xtrallux™Xtrallux, LLCOAP2025-07-01
00850049532440HIGHERDOSEShenzhen Kaiyan Medical Equipment Co,. LtdOAP2025-06-28
00850062024557EXOCEUTICALSShenzhen Kaiyan Medical Equipment Co,. LtdOAP2025-06-28
06970006970918NOOANCEShenzhen Kaiyan Medical Equipment Co,. LtdOAP2025-06-28
06970006970925NOOANCEShenzhen Kaiyan Medical Equipment Co,. LtdOAP2025-06-28
06978743639853Diode Laser CapCosmo Far East Technology LimitedOAP2025-06-26
00850003374161GetHairMDRevian, Inc.OAP2025-05-07
06975488665482BreoShenzhen Breo Technology Co., Ltd.OAP2025-01-14
06975488664256BreoShenzhen Breo Technology Co., Ltd.OAP2024-12-25
00850523007761CellumaBiophotas, Inc.OAP2024-12-23
00850523007730CellumaBiophotas, Inc.OAP2024-12-20