Innovaquartz LLC
Phoenix, AZ, US
INNOVAQUARTZ LLC appears in FDA device records in Phoenix, AZ. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Innovaquartz LLC between 1999 and 2024. The busiest year on record is 1999, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2005 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | GEX | Substantially Equivalent | |
| K203799 | ProFlex CO2 Laser Fiber | GEX | Substantially Equivalent | |
| K180140 | ProFlex Laser Fibers | GEX | Substantially Equivalent | |
| K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | GEX | Substantially Equivalent | |
| K050108 | SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS | GEX | Substantially Equivalent | |
| K994010 | INNOVAQUARTZ GENERAL SHAPE LASER FIBER | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010933841 | 3010933841 | INNOVAQUARTZ LLC | 23030 N 15TH AVE, Phoenix, AZ 85027 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain