FDA.reportPublic FDA data

Thulium Fiber Laser System

Primary DI
06973204212392
Brand
Thulium Fiber Laser System
Company
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Model
TFL-A
Published
2026-04-01
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
K252787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252787000Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.2025-11-24GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973204212392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973204212392069732042123926973204212392

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
06973204212255Holmium Laser Therapeutic ApparatusHZ-402026-04-03
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16