Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innovaquartz, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | Innovaquartz, LLC | 2024-05-03 | 219 | 0 |
| K203799 | ProFlex CO2 Laser Fiber | Innovaquartz, LLC | 2021-09-20 | 266 | 0 |
| K180140 | ProFlex Laser Fibers | Innovaquartz, LLC | 2018-04-20 | 92 | 0 |
| K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers | Innovaquartz, LLC | 2014-12-19 | 93 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda