510(k) · Cleared
ClearedSurgical Lightstic, Models, 180 L, and 180 C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiofocus, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 4, 2000 after an 84-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.
- Decided
- Feb 4, 2000
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 1 citing it directly.
- This deviceK993834 Surgical Lightstic, Models, 180 L, and 180 CCardiofocus, Inc. · 2000
- Descendant · cites it directly · 31 of its ownK011988 Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
- Descendant · 2 generations on · 30 of its ownK013901 Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
- Descendant · 3 generations on · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
- Descendant · 2 generations on · 22 of its ownK040641 Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8…Epicor Medical, Inc. · 2004
- Descendant · 3 generations on · 18 of its ownK043579 Atricure Bipolar SystemAtriCure, Inc. · 2007
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K011988Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001 · cites it directly31descendants
- K013901Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001 · 2 generations on30descendants
- K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · 3 generations on23descendants
- K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11…Epicor Medical, Inc. · 2004 · 2 generations on22descendants
- K043579Atricure Bipolar SystemAtriCure, Inc. · 2007 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993834 | Surgical Lightstic, Models, 180 L, and 180 C | Cardiofocus, Inc. | 2000 | — |
| +1 | K011988 | Surgical Lightstic 180, Model 180 L, Model 180 C | Cardiofocus, Inc. | 2001 | — |
| +2 | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) | Cardiofocus, Inc. | 2001 | — |
| +3 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
| +2 | K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9… | Epicor Medical, Inc. | 2004 | — |
| +3 | K043579 | Atricure Bipolar System | AtriCure, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | — | Rare Earth Medical Lightstic Model 180 Named without a submission number | |
| * | — | Dornier’s Lasertrode Fiber Named without a submission number | |
| * | — | Xintec’s Polaris Diode Laser System and Accessories Named without a submission number | |
| * | — | CeramOptec’s Ceralas Diode Laser Systems Named without a submission number |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011988 | Surgical Lightstic 180, Model 180 L, Model 180 C | 2001 | 31 |
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?
- Of its descendants, K011988 (Cardiofocus, Inc., 2001) has gone furthest, with 31 descendants of its own.
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 Surgical Lightstic™ 180 is intended to be used as 2 surgical instrument for coagulation of soft tissue in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).
The Surgical Lightstic™ 180 is indicated for use in medicine and surgery with 980 — 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Plastic Surgery, and Dermatology.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993834: Surgical Lightstic, Models, 180 L, and 180 C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993834
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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