# K213252: Dornier Thulio

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America, Inc.
- Decided: Jul 27, 2022 after 300 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 4.

## Indications for use
The Dornier Thulio Laser is intended for minimally-invasive stone fragmentation, surgical tissue preparation such as cutting, ablation, coagulation and vaporization, in the following medical specialties: Urology a) Lithotripsy - Endoscopic fragmentation and pulverization of urethral, ureteral, bladder and renal stones b) Benign Prostatic Hyperplasia (BPH) c) Urethral Strictures d) Bladder Neck Incision of the Prostate (BNI) e) Superficial and invasive bladder, urethral and ureteral tumors

Source page: https://510kreport.com/device/K213252
Methodology: https://510kreport.com/methodology