FDA.reportPublic FDA data

Diode Laser Hair Removal machine

Primary DI
06971679500013
Brand
Diode Laser Hair Removal machine
Company
Beijing Nubway S&T Co., Ltd.
Model
QDTM-01
Published
2020-07-23
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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192735000Diode Laser Hair Removal MachineBeijing Lead Beauty S & T Co., Ltd.2020-04-03GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971679500013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971679500013069716795000136971679500013

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540583535
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971679500105LED Therapy DeviceQLXY-012026-09-24
06971679500624NubwayQDTM-022025-05-17
06971679500914NubwayQNHF-012025-05-17
06971679500020Q Switched Nd:YAG Laser machineQLHF-022020-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817495025216Refurbished Vbeam PerfectaCandela CorporationGEX2026-11-04
00817495025223Refurbished Vbeam PerfectaCandela CorporationGEX2026-11-04
06973511890214SANOBeijing Sano Lasers S&T Development Co., Ltd.GEX2026-10-30
06973011720134Diode Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-10-16
00840456400814MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456400821MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401293MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401309MOSES RaydarLUMENIS LTD.GEX2026-10-13
B17731226455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-10-08
B17700100852TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
B17700100853TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
06970745912927ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912934ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912996ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
04053002150316Bare Fiber 400 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150415Bare Fiber 600 T Luer LockLight Guide Optics International SIAGEX2026-08-14
04053002150514CORONA 360 Fused 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
04053002150613CORONA Infinite Ring XSCF 600 1.6 USLight Guide Optics International SIAGEX2026-08-14
04053002150712Rigid Infinite Ring HSC Probe 600 1.8 USLight Guide Optics International SIAGEX2026-08-14
06973011720080CO2 Laser Therapy SystemSanhe LEFIS Electronics Co., LtdGEX2026-08-07
06973011720103Q Switched Nd: YAG Laser machineSanhe LEFIS Electronics Co., LtdGEX2026-08-07
00872320007195Picasso Pro Pre-initiated Laser Tip, Variety PackCAO GROUP, INC.GEX2026-08-03
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29