510(k) · Cleared
ClearedProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)
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 Dec 19, 2014 as substantially equivalent to K972272 (Laser Peripherals, LLC, 1997) and 1 other predicate after a 93-day review. Its family tree reaches back 1 generation to 1997. 15 later devices descend from it.
- Decided
- Dec 19, 2014
- Review
- 93 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972272 (1997). 2 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK972272 Laser Peripherals Holmium Bare FibersLaser Peripherals, LLC · 1997
- This deviceK142638 ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex…Innovaquartz, LLC · 2014
- Descendant · cites it directly · 13 of its ownK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- Descendant · 2 generations on · 5 of its ownK220189 LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK241643 WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd. · 2025
- Descendant · 2 generations on · 2 of its ownK200234 Surgical laser fibersQuanta System Spa · 2020
- Descendant · 4 generations on · 1 of its ownK252745 Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd. · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017 · cites it directly13descendants
- K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc. · 2022 · 2 generations on5descendants
- K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd. · 2025 · 3 generations on2descendants
- K200234Surgical laser fibersQuanta System Spa · 2020 · 2 generations on2descendants
- K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972272 | Laser Peripherals Holmium Bare Fibers | Laser Peripherals, LLC | 1997 | — |
| 0 (this device) | K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | Innovaquartz, LLC | 2014 | — |
| +1 | K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Laser Peripherals, LLC | 2017 | — |
| +2 | K220189 | LISA Laser Surgical Fibers | Omni-Guide Holdings, Inc. | 2022 | — |
| +3 | K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Wontech Co., Ltd. | 2025 | — |
| +2 | K200234 | Surgical laser fibers | Quanta System Spa | 2020 | — |
| +4 | K252745 | Halo Sterile Single-use Radial Fiber… | Micro-Energy Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K972272 | Laser Peripherals Holmium Bare FibersSummary page 4…nt for use in general and plastic surgery and in dermatology – 21 CFR 878.4810, Class II 510(k) Number: K972272 issued to Laser Peripherals, Inc., 1000 Boone Ave. North, Suite 300, Golden Valley, MN… | 1997 |
| * | K050108 | Sureflex and Accuflex Laser Lithotripsy FibersSummary page 5…nt for use in general and plastic surgery and in dermatology – 21 CFR 878.4810, Class II 510(k) Number: K050108 awarded to InnovaQuartz Incorporated, 23030 N 15th Ave, Phoenix, AZ 85027 and now held… | 2005 |
What descends from it? (15)
See all 152 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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 (102 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™ fibers may be used with any laser wavelength between 500nm and 2200nm 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142638: ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142638
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