FDA.reportPublic FDA data

Breo

Primary DI
06975488664256
Brand
Breo
Company
Shenzhen Breo Technology Co., Ltd.
Model
N/A
Published
2024-12-25
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric
OAPLaser, Comb, Hair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1
OAPLaser, Comb, HairPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242620000Breo Laser Hair Growth Comb (Scalp 3L)Shenzhen Breo Technology Co., Ltd.2024-11-01OAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975488664256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975488664256069754886642566975488664256

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
529175390
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975488665482BreoScalp 3L2025-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810140063229Renpho RejuvenJoicom CorporationISA2026-10-20
00850079561632CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-10-16
00850079561649CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-10-16
00810226442610ViveVIVE HEALTH LLCISA2026-10-09
00810226442627ViveVIVE HEALTH LLCISA2026-10-09
00810226442634ViveVIVE HEALTH LLCISA2026-10-09
00810226442641ViveVIVE HEALTH LLCISA2026-10-09
00850018480888Primo PassiPrimo Passi LLCISA2026-09-21
00860014139918QUASONIQ+Global Good, Corp.ISA2026-09-21
06953808301241Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-10
06953808301265Laser Hair Growth SystemHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-09-10
06977444420005Shuhai JingweiShuhai Jingwei (Shenzhen) Information Technology Co., Ltd.ISA2026-09-04
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
08800250281332QuadtheraECO DM LAB Co., Ltd.ISA2026-08-21
00817915020296Etekcity Smart Fitness ScaleVesync (US) CorporationISA2026-08-14
088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976913H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977073H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977143H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977213H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977383H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977453H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977523H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976773H Smart Massage Bed3H, Co., LtdISA2026-07-28
00810140063106Renpho Massage GunJoicom CorporationISA2026-07-21
06974958310587ideatherapyShenzhen Idea Light LimitedOAP2026-07-09
06977638360483Hair Growth DeviceDongguan Boyuan Intelligent Technology Co.,LtdOAP2026-07-09