FDA.reportPublic FDA data

Actonis,Hairmax

Primary DI
00856823006305
Brand
Actonis,Hairmax
Company
Lexington International, LLC
Model
HXXXYY
Catalog number
KHXXXYYzzzzzzzz
Device description
Lower Level Laser Therapy DeviceK-KitH-HandheldXXX-Laser CountYY-Product Configurationzzzzzzzz-Logistics and Supply Chain identifiers
Published
2023-12-05
Public version status
Update
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
K103368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103368000HAIRMAX LASERCOMBLexington International, LLC2011-04-06OAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856823006305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856823006305008568230063058568230063050856823006305

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
104265165
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856823006251HairMaxUltima 92021-12-10
00856823006534HairMaxUltima 9 Classic8568230065342021-12-10
00856823006732HairMaxProfessional 12-LC8568230067322021-12-10
00856823006138HairMaxLaserComb Prima 7PRIMA 7 - KIT2016-09-22
00856823006145HairMaxLaserComb Ultima 12ULTIMA 12 - KIT2016-09-22
00850016973047HairMaxBXXXYYKBXXXYYzzzzzzzz2021-12-10
00856823006046HairMaxCXXXYYKCXXXYYzzzzzzzz2023-05-19
00850016973481HairmaxPro 12 LaserComb8500169734812022-03-31
00856823006510HairMaxLaserBand 418568230065102021-12-10
00850016973078HairMaxLaser 80 - Corded 8500169730782020-09-25
00856823006619HairMaxRegrowMD Laser 2728568230066192020-09-25
00856823006701HairMaxLaser 80 - Rechargeable8568230067012020-09-25
00856823006718HairMaxLaser 2028568230067182020-09-25
00856823006725HairMaxLaser 272 PowerFlex8568230067252020-09-25
00856823006008HairMaxLaserComb 41 - LaserBand 41LB41-LASERBAND-KIT2016-09-22
00856823006152HairMaxLaserComb 82 - LaserBand 828568230061522016-09-22

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