510(k) · Cleared
ClearedProFlex Laser Fibers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovaquartz, LLC · GEX Powered Laser Surgical Instrument
Cleared on Apr 20, 2018 as substantially equivalent to K142638 (Innovaquartz, LLC, 2014) after a 92-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Apr 20, 2018
- Review
- 92 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972272 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972272 | Laser Peripherals Holmium Bare Fibers | Laser Peripherals, LLC | 1997 | — |
| −1 | K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | Innovaquartz, LLC | 2014 | — |
| 0 (this device) | K180140 | ProFlex Laser Fibers | Innovaquartz, LLC | 2018 | — |
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? (1)
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 |
|---|---|---|---|
| * | K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)Summary page 4…ic Surgery Subject devices are substantially equivalent to the primary predicate devices. Predicate Device(s): Primary Predicate Device: ProFlex® Laser Fibers (K142638) Reference Predicate: EndoBeam™ Holmium Laser Fibers (K120926) Device Description: Subject dev… | 2014 |
| † | K120926 | Endobeam Holmium Laser Fibers | 2012 |
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 21 years and passes through 2 companies; a new generation was cleared every 17.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K142638.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
ProFlex® Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho:YAG) lasers…
Read the full statement (105 words)
ProFlex® Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho:YAG) lasers, ProFlex laser fibers may be used with any laser wavelength between 500 nm and 2200 nm that have been cleared for surgical use including, but not limited to frequency doubled Nd:YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180140 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180140: ProFlex Laser Fibers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180140
Report an extraction error
Are you the manufacturer?
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