FDA.reportPublic FDA data

HAIRCLUB RX™

Primary DI
00840223306004
Brand
HAIRCLUB RX™
Company
Xtrallux, LLC
Model
HairClub RX™ Elite
Device description
HairClub RX™ Elite Laser Cap - Hair Growth Laser Light Device
Published
2026-03-30
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222364000Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)Xtrallux, LLC2022-11-16OAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840223306004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840223306004008402233060048402233060040840223306004

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
036992284
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007783470Xtrallux™Xtrallux™ Advanced2026-04-02
00860007783487Xtrallux™Xtrallux™ Premium2026-04-02
00860007783494Xtrallux™ Xtrallux™ Elite 2026-04-02
00840223305984HAIRCLUB RX™HairClub RX™ Advanced2026-03-30
00840223305991HAIRCLUB RX™HairClub RX™ Premium2026-03-30
00860007783456Xtrallux™Laser Comb Alpha2025-07-01
00860007783401Xtrallux™Xtrallux™ Alpha2023-11-17
00860007783418Xtrallux™Xtrallux™ Super Plus Reg Size 2023-11-17
00860007783425Xtrallux™Xtrallux™ Super Plus2023-11-17
00860007783432Xtrallux™Xtrallux™ Turbo Pro 2023-11-17
00860007783449Xtrallux™Xtrallux™ Extreme RX2023-11-17

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
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
00810045461458CapillusCAPILLUS, LLCOAP2024-12-19