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510(k) Data Aggregation
K Number
K243121Device Name
SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;
Manufacturer
JiangXi Medex Technology Co.,Ltd
Date Cleared
2024-12-22
(83 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
JiangXi Medex Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905connector.
·Laser must operate at a wavelength between 532 and 1064 nm.
* Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.
- · Laser must have a numerical aperture of 0.35 or less.
· Laser must accept universal SMA-905 connector, SLT proprietary connector, or an appropriate adapter into its fiber launch connector.
Note: These Fiber Delivery Systems are cleared for the particular indications of the laser system to which they are connected.
During use these products are exposed to biohazardous substances such as blood and other bodily fluids. They should be disposed of per your facility's procedures for biohazardous waste.
Device Description
The SLT select fiber delivery system and contact tips is the transmission path for 810mm, 980mm wavelength laser generator to the surgical site, with the optical fiber as the propagation medium, by transmitting the diseased area, to achieve the treatment of the disease.
The SLT select fiber delivery system and contact tips, except for the CFE series of needle-tip one-piece flexible fibers, are fitted with a metal connector at the metal connector is threaded to connect to the contact laser tread, The FEF series models can be used as non-contact lasers without a treatment head.
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