510(k) Report

FDA applicant

Innovaquartz, LLC

Phoenix, AZ6 decisions1999–20246 recalls

FDA records 6 decisions for Innovaquartz, LLC (Phoenix, AZ) from 1999 to 2024: 6 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 219 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 2 of them its own earlier devices. 6 recalls are linked to its devices.

FDA’s records also spell it “Innovaquartz”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Innovaquartz, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014: 12018: 12021: 12024: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

6in 2015

2015: 6
2007high 6 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Innovaquartz, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Innovaquartz, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument6decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 219 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050108Sureflex and Accuflex Laser Lithotripsy FibersInnovaquartz · 20057cite it
  • K994010Innovaquartz General Shape Laser FiberInnovaquartz · 19995cite it
  • K142638ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)Innovaquartz, LLC · 20142cite it
  • K203799ProFlex CO2 Laser FiberInnovaquartz, LLC · 20211cites it

What has FDA decided for it lately?

  • K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC · 2024
  • K203799ProFlex CO2 Laser FiberInnovaquartz, LLC · 2021
  • K180140ProFlex Laser FibersInnovaquartz, LLC · 2018
  • K142638ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)Innovaquartz, LLC · 2014
  • K050108Sureflex and Accuflex Laser Lithotripsy FibersInnovaquartz · 20056 recalls
  • K994010Innovaquartz General Shape Laser FiberInnovaquartz · 1999

All 4 as Innovaquartz, LLC →All 2 as Innovaquartz →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K050108Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in…May 28, 2015Class II
  • K050108Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in…May 28, 2015Class II
  • K050108Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in…May 28, 2015Class II
  • K050108Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in…May 28, 2015Class II
  • K050108Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in…May 28, 2015Class II
  • K050108Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in…May 28, 2015Class II