510(k) · Cleared
ClearedSLT Select Fiber Delivery System and Contact Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Laser Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 27, 1998 after a 42-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Feb 27, 1998
- Review
- 42 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK980156 SLT Select Fiber Delivery System and Contact TipsSurgical Laser Technologies, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK243121 SLT Select Fiber Delivery System and Contact Tips (models: SSRH…Jiangxi Medex Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK030033 Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980156 | SLT Select Fiber Delivery System and Contact Tips | Surgical Laser Technologies, Inc. | 1998 | — |
| +1 | K243121 | SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH… | Jiangxi Medex Technology Co., Ltd. | 2024 | — |
| +1 | K030033 | Lumenis Family of Disposable Contact Tip Delivery Devices | Lumenis, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2024 | 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?
The FDA summary names no predicate by number.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K243121 (Jiangxi Medex Technology Co., Ltd., 2024) has gone furthest, with 0 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 SLT Select Fiber Delivery Systems and Contact Tips are indicated for use in General Surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic Surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-S05 connector aliows this family…
Read the full statement (142 words)
The SLT Select Fiber Delivery Systems and Contact Tips are indicated for use in General Surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic Surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-S05 connector aliows this family of fiber delivery systems and tips to be used with any laser system meeting the following requirements:
Laser must operate at a wavelength between 532 and 1064 nanometers.
Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.
Laser must have a numerical apertures of 0.39 or less
Laser must accept the universal SMA-805 connector.
Fiber Delivery Systems are cleared for use for the particular indications of the laser system to which they are attached.
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/K980156 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980156: SLT Select Fiber Delivery System and Contact Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980156
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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