# K980156: SLT Select Fiber Delivery System and Contact Tips

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Laser Technologies, Inc.
- Decided: Feb 27, 1998 after 42 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- 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; (2024), 0 descendants of its own
- K030033: Lumenis Family of Disposable Contact Tip Delivery Devices (2003), 0 descendants of its own

## Indications for use
The SLT Select Fiber Delivery Systems and Contact Tips are indicated for use 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 achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-S05 connector aliows this family of fiber delivery systems and tips to be used with any laser system meeting the following requirements: Laser must operate at a wavelength between 532 and 1064 nanometers. Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode. Laser must have a numerical apertures of 0.39 or less Laser must accept the universal SMA-805 connector. Fiber Delivery Systems are cleared for use for the particular indications of the laser system to which they are attached.

Source page: https://510kreport.com/device/K980156
Methodology: https://510kreport.com/methodology