FDA.reportPublic FDA data

Hair Boom

Primary DI
08800022300674
Brand
Hair Boom
Company
WONTECH CO.,LTD
Model
Hair Boom
Device description
Low level laser therapy device
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K182562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182562000Hair Boom 69Wontech2018-11-16OAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800022300674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800022300674088000223006748800022300674

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. It may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695658263
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800022304108SANDRO DualSANDRO Dual2020-06-16
08800022304412PICOALEXPICOALEX2025-03-25
08800022300803PastellePastelle2017-08-16
08800022304405PicowonPicowon2020-10-06
08800022300209Cosjet SRCosjet SR2017-08-16
08800022305327Oligio XOligio X2024-03-21
08800022305310The OligioThe Oligio2023-02-17
08800022304016ALMA VEIL; V-LaserALMA VEIL; V-Laser2023-08-24
08800022301404VeincareVeincare2024-12-17
08800022301800WONTECH Surgical Optic FibersBA4002025-02-24
08800022301817WONTECH Surgical Optic FibersBA6002025-02-24
08800022301824WONTECH Surgical Optic FibersBA400R2025-02-24
08800022301831WONTECH Surgical Optic FibersBA600R2025-02-24
08800022302906Pastelle ProPastelle Pro2025-02-24
08800022301121NOUVADermNOUVADerm2024-10-04
08800022301107LavieenLavieen2023-09-20
08800022305600PICOCAREMAJESTYPICOCAREMAJESTY2022-02-01
08800022305914PICOANDYPICOANDY2024-03-21
08800022304009V-LaserV-Laser2019-05-21
08800022304924Hair Boom69, Hair Beam Air, Hair Boom, Hair Boom Air, Ulike Hair UpUpHair Boom69, Hair Beam Air, Hair Boom, Hair Boom A2019-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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