Innovaquartz

FDA Regulatory Profile

Innovaquartz appears in FDA public data with 0 recalls, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Dec 14, 2017 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on May 3, 2024.

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Summary

Total Recalls
0
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 14, 2017Phoenix, AZDevicesNo Action Indicated (NAI)3010933841

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDMay 3, 2024
K203799ProFlex CO2 Laser FiberSep 20, 2021
K180140ProFlex Laser FibersApr 20, 2018
K142638ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)Dec 19, 2014
K050108SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERSMar 14, 2005
K994010INNOVAQUARTZ GENERAL SHAPE LASER FIBERDec 17, 1999