510(k) · Cleared
ClearedLaser Peripherals Holmium Bare Fibers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laser Peripherals, LLC · GEX Powered Laser Surgical Instrument
Cleared on Jul 29, 1997 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 48 later devices descend from it.
- Decided
- Jul 29, 1997
- Review
- 41 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 6 citing it directly.
- This deviceK972272 Laser Peripherals Holmium Bare FibersLaser Peripherals, LLC · 1997
- Descendant · cites it directly · 24 of its ownK120926 Endobeam Holmium Laser FibersC.R. Bard, Inc. · 2012
- Descendant · cites it directly · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- Descendant · cites it directly · 19 of its ownK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
- Descendant · 2 generations on · 18 of its ownK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
- Descendant · 3 generations on · 17 of its ownK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K120926Endobeam Holmium Laser FibersC.R. Bard, Inc. · 2012 · cites it directly24descendants
- K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · cites it directly23descendants
- K022610Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160Clarus Medical, LLC · 2002 · cites it directly19descendants
- K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…Clarus Medical, LLC · 2004 · 2 generations on18descendants
- K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972272 | Laser Peripherals Holmium Bare Fibers | Laser Peripherals, LLC | 1997 | — |
| +1 | K120926 | Endobeam Holmium Laser Fibers | C.R. Bard, Inc. | 2012 | — |
| +1 | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers… | Med-Fibers, Inc. | 2013 | — |
| +1 | K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser… | Clarus Medical, LLC | 2002 | — |
| +2 | K040424 | Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy… | Clarus Medical, LLC | 2004 | 1 |
| +3 | K040919 | Nucleotome Probe Set, Model 21200 | Clarus Medical, LLC | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (48)
See all 486 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120926 | Endobeam Holmium Laser Fibers | 2012 | 24 |
| K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and… | 2013 | 23 |
| K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160 | 2002 | 19 |
| K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | 2014 | 15 |
| K131473 | (Quanta System) Surgical Laser Fibers | 2013 | 5 |
| K021848 | Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160 | 2002 | 0 |
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, K120926 (C.R. Bard, Inc., 2012) has gone furthest, with 24 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 Laser Peripherals Holmium Bare Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, coagulation, incision, excision, and vaporization. The delivery system may be used in each surgical specialty or procedure for which compatible Holmium and Nd: YAG lasers have received regulatory clearance.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972272: Laser Peripherals Holmium Bare Fibers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972272
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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