Data / Medical devices / United States / Innovaquartz LLC
Innovaquartz LLC: FDA-registered device maker in Phoenix, AZ, United States, 4 510(k) clearances
Innovaquartz LLC is registered with the FDA (registration 3010933841) in Phoenix, AZ, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated May 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010933841
- Address
- 23030 N 15TH Ave, Phoenix, AZ, United States, 85027
- Owner or operator
- InnovaQuartz LLC (10048474)
- Roles
- Manufacturer
- First device listed
- January 16, 2015
- Registered through
- 2026
- Brand names listed
- DragonFire, MegaJOULE LDD, MegaJoule LDD, ProFlex, ProFlex LLF, ProFlex Laser Fiber, VaporMax
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 3, 2024 | K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | GEX | Substantially Equivalent | Innovaquartz, LLC | accessdata.fda.gov |
| April 20, 2018 | K180140 | ProFlex Laser Fibers | GEX | Substantially Equivalent | Innovaquartz, LLC | accessdata.fda.gov |
| December 19, 2014 | K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | GEX | Substantially Equivalent | Innovaquartz, LLC | accessdata.fda.gov |
| March 14, 2005 | K050412 | VAPORMAX | GEX | Substantially Equivalent | Trimedyne, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 3, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.