FDA.reportPublic FDA data

Laser Hair Growth System

Primary DI
06953808301241
Brand
Laser Hair Growth System
Company
Hubei YJT Intelligent Technology Group Co., Ltd.
Model
Laser Helmet 272
Published
2026-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K253231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253231000Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,Ltd2026-06-16OAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06953808301241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06953808301241069538083012416953808301241

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
529472637
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06953808301265Laser Hair Growth SystemLaser Helmet 5002026-09-10
06953808301692Laser Hair Growth SystemLaser Cap 1282026-09-01
06953808301739Laser Hair Growth SystemLaser Helmet 3522026-09-01
06953808301746Laser Hair Growth SystemLaser Helmet 5522026-09-01
06953808301777Laser Therapy Hair Growth CombLasercomb-0022026-09-01
06953808300503Laser CapHat-012026-04-29
06953808300510Laser Therapy Hair Growth CombLasercomb-0012026-04-29
06953808300527Laser Therapy Hair Growth CombLasercomb-0022026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079561632CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-10-16
00850079561649CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-10-16
06953808301265Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-10
06953808301692Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-01
06953808301739Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-01
06953808301746Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-01
06953808301777Laser Therapy Hair Growth CombHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-01
06974958310587ideatherapyShenzhen Idea Light LimitedOAP2026-07-09
06977638360483Hair Growth DeviceDongguan Boyuan Intelligent Technology Co.,LtdOAP2026-07-09
06977638360612Hair Growth DeviceDongguan Boyuan Intelligent Technology Co.,LtdOAP2026-07-09
00731093153129CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
00850079561014CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
00860011935582CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
00860011935599CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
06970006973285CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
05061091983134Beauty PieLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDOAP2026-06-23
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