# K972548: SLT CL MD Contact Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Laser Technologies, Inc.
- Decided: Apr 21, 1998 after 287 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary reads “K902241”, which our checks could not confirm as its predicate.
- (no number) Traditional Electrosurgical Procedure (TURP): named in the summary without a submission number

## Indications for use
The specific indication for use of the SLT® Contact Laser™ Fiber Delivery System is for the Incision, Excision, Coagulation and Vaporization of soft tissue for prostatectomy in treatment of Benign Prostatic Hyperplasia (BPH). Vaporization of Prostatic Tissue - The Contact Laser Vaporization of the Prostate (CLVP) procedure vaporizes prostate lobe tissue as well as tissue obstructing the urinary channel. This procedure is indicated for prostates up to 45 grams in size. Coagulation and Vaporization of Prostatic Tissue - The Coagulation and Hemostatic Resection of the Prostate (CHRP)™ coagulates the prostate lobe tissue and vaporizes tissue obstructing the urinary channel. This procedure is indicated for prostates up to 75 grams.

Source page: https://510kreport.com/device/K972548
Methodology: https://510kreport.com/methodology