# K060752: Acmi Dur-HL Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Acmi Corporation
- Decided: May 25, 2006 after 65 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 K964760 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051399: Wavelight Auriga, Wavelight Laser Technologie AG (2005) Summary page 1.
- K983963: Dornier Medila H, Dornier Medtech America, Inc. (1998) Summary page 1.

## Indications for use
The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysterosoopic, bronchoscopic, gastroenteroscopic and colonoscopic) brealdng up stones, cutfing (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Castroenteroology, Gynecology, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery

Source page: https://510kreport.com/device/K060752
Methodology: https://510kreport.com/methodology