# K152220: MH01

- Pathway: 510(k) (Special)
- Applicant: Quanta System Spa
- Decided: Sep 3, 2015 after 27 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: 3 generations back to K033437 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141403: Litho DK30, Quanta System Spa (2014) Summary page 5.

## Indications for use
The MH01 laser system, 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. It is indicated 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/K152220
Methodology: https://510kreport.com/methodology