FDA.reportPublic FDA data

Nubway

Primary DI
06971679500914
Brand
Nubway
Company
Beijing Nubway S&T Co., Ltd.
Model
QNHF-01
Device description
Q Switched Nd: YAG Laser machine (QNHF-01) is laser system which delivers las:er at a wavelength 1064nm or 532nm. It consists of control panelmodule, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel
Published
2025-05-17
Public version status
New
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
K242943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242943000Q Switched Nd:YAG Laser machine (QNHF-01)Beijing Nubway S&T Co., Ltd.2025-03-03GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971679500914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971679500914069716795009146971679500914

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540583535
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
06971679500105LED Therapy DeviceQLXY-012026-09-24
06971679500624NubwayQDTM-022025-05-17
06971679500013Diode Laser Hair Removal machineQDTM-012020-07-23
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