FDA.reportPublic FDA data

Holmium Laser Therapeutic Apparatus

Primary DI
06973204212255
Brand
Holmium Laser Therapeutic Apparatus
Company
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Model
HZ-40
Published
2026-04-03
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
K253633000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253633000Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.2026-01-24GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973204212255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973204212255069732042122556973204212255

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Regulatory Flags#

DUNS number
540482563
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973204211760Laser FiberPT-OF-A-S2026-04-03
06973204211777Laser FiberPT-OF-B-S2026-04-03
06973204211784Laser FiberPT-OF-C-S2026-04-03
06973204211791Laser FiberPT-OF-D-S2026-04-03
06973204211807Laser FiberPT-OF-E-S2026-04-03
06973204211814Laser FiberPT-OF-F-S2026-04-03
06973204212378Holmium Laser SystemPotent HP1402026-04-03
06973204212385Holmium Laser SystemPotent HP1502026-04-03
06973204212248Holmium Laser Therapeutic ApparatusHZ-E2026-04-02
06973204212361Holmium Laser SystemPotent HP902026-04-02
06973204212422Holmium Laser SystemPotent HP1002026-04-02
06973204212439Holmium Laser SystemPotent HP1202026-04-02
06973204212224Holmium Laser Therapeutic ApparatusHZ-A2026-04-01
06973204212231Holmium Laser Therapeutic ApparatusHZ-B2026-04-01
06973204212392Thulium Fiber Laser SystemTFL-A2026-04-01
06973204212408Thulium Fiber Laser SystemTFL-B2026-04-01
06973204210763Electrohydraulic LithotriptorTCS-B3-II2025-06-26
06973204210787EHL ProbeSCDG - AS2025-06-26
06973204210794EHL ProbeSCDG - BS2025-06-26
06973204210800EHL ProbeSCDG - CS2025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07