# K260100: MOSES Raydar™

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: May 18, 2026 after 125 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: 8 generations back to K936109 (1994). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170121: Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories, Lumenis, Ltd. (2017) Summary page 5.

## Indications for use
The MOSES Raydar T M system with delivery fibers and accessories are indicated for use in the performance of specific surgical applications in Urology as follows: * Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), hemostasis, vaporization, and excision for treatment of benign prostatic hyperplasia (BPH). * Endoscopic urological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of: o Bladder o Bladder, urethral and ureteral tumors o Ureteral strictures * Urinary Lithotripsy including: o Endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate, and calcium oxalate dihydrate stones.

Source page: https://510kreport.com/device/K260100
Methodology: https://510kreport.com/methodology