FDA.reportPublic FDA data

Medical Thulium Fiber Laser Systems

Primary DI
06976812430158
Brand
Medical Thulium Fiber Laser Systems
Company
Rhein Laser Technologies Co.,Ltd.
Model
UroFiber 60Q
Published
2025-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K242293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242293000Medical Thulium Fiber Laser Systems (UroFiber 60Q)Rhein Laser Technologies Co., Ltd.2024-11-19GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976812430158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976812430158069768124301586976812430158

GMDN Terms#

Term, Definition table
TermDefinition
Laser lithotripsy systemAn assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). The assembly transmits the laser energy to the stone(s) which fragment. The debris may be removed forcefully or passed out later by natural means.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
704587822
Device count
1
Lot or batch
true
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
06976812430219TheraLight 360 Full Body WellnessTHERALIGHT 360 2026-03-06
06976812430226TheraLight 360 Full Body WellnessTHERALIGHT 10X 2026-03-06
06976812430233TheraLight 360 Full Body WellnessTHERALIGHT FIT2026-03-06
06976812430202Smart Laser Therapy SystemSMART-S60D2026-01-19
06976812430127Artemis Diode Laser SystemRL-S20S-TWC2024-09-14
06976812430134Artemis Diode Laser SystemRL-S20S-810B2024-09-14
06976812430141Artemis Diode Laser SystemRL-S20S-7552024-09-14
06976812430110TitanPico Laser WorkstationPICO-4502024-09-12

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Primary DI, Brand, Company table
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