510(k) · Cleared
ClearedAcmi Dur-HL Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · GEX Powered Laser Surgical Instrument
Cleared on May 25, 2006 as substantially equivalent to K051399 (Wavelight Laser Technologie AG, 2005) and 1 other predicate after a 65-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 25, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K964760 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK964760 Dornier Medilas Fiber Tome LaserDornier Medtech America, Inc. · 1997
- 2 generations backK981718 Dornier Medilas HDornier Surgical Products, Inc. · 1998
- 1 generation backK983963 Dornier Medila HDornier Medtech America, Inc. · 1998
- This deviceK060752 Acmi Dur-HL Laser SystemsAcmi Corporation · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964760 | Dornier Medilas Fiber Tome Laser | Dornier Medtech America, Inc. | 1997 | — |
| −2 | K981718 | Dornier Medilas H | Dornier Surgical Products, Inc. | 1998 | — |
| −1 | K983963 | Dornier Medila H | Dornier Medtech America, Inc. | 1998 | — |
| 0 (this device) | K060752 | Acmi Dur-HL Laser Systems | Acmi Corporation | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051399 | Wavelight AurigaSummary page 1…ACMI® DUR-HL Laser Systems Generic/Common Name: Laser, Holmium YAG, Surgical Predicate Devices WaveLight Auriga Laser K05 1399 Domier Medilas H Laser Systems K983963 IntendedUses The ACMI® DUR-HL Laser Systems are intended to be used in su… | 2005 |
| * | K983963 | Dornier Medila HSummary page 1…Laser, Holmium YAG, Surgical Predicate Devices WaveLight Auriga Laser K05 1399 Domier Medilas H Laser Systems K983963 IntendedUses The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoseopic (lapar… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K051399.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060752: Acmi Dur-HL Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060752
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026