# K141101: LITHO

- Pathway: 510(k) (Special)
- Applicant: Quanta System Spa
- Decided: Aug 8, 2014 after 101 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: 2 generations back to K033437 (2004). 2 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091909: Litho Laser System, Quanta System Spa (2009) Summary page 1.

## Most influential descendants
- K163009: Litho (2016), 12 descendants of its own
- K170331: Cyber Ho (2017), 9 descendants of its own
- K172025: Litho 60 (2017), 8 descendants of its own
- K180922: Empower H100, Cyber Ho 100, Litho 100 (2018), 6 descendants of its own
- K192600: Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 (2020), 5 descendants of its own

## Indications for use
INTENDED USE The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones. INDICATIONS FOR USE The device Litho including a fiber optic delivery system is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to: - Urology - Gastroenterology - Arthroscopy - Neurosurgery - Pulmonary - Gynecology - ENT - Dermatology - Plastic Surgery - General Surgery

Source page: https://510kreport.com/device/K141101
Methodology: https://510kreport.com/methodology