# K243121: 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;

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Medex Technology Co., Ltd.
- Decided: Dec 22, 2024 after 83 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980156 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980156: SLT Select Fiber Delivery System and Contact Tips, Surgical Laser Technologies, Inc. (1998) Summary page 6.

## Indications for 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 and coagulation 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-905 connector. ·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 use 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.

Source page: https://510kreport.com/device/K243121
Methodology: https://510kreport.com/methodology