# Innovaquartz, LLC

- Location (FDA's records): Phoenix, AZ
- FDA decisions: 6 (1999–2024): 6 510(k) clearances
- Names in FDA's records: Innovaquartz, LLC (4); Innovaquartz (2)
- Product codes: GEX (6)
- 510(k) review time since 2016: median 219 days, against 90 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 15 (2 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Laser Peripherals, LLC: 2 (https://510kreport.com/company/laser-peripherals)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)
- Trimedyne, Inc.: 1 (https://510kreport.com/company/trimedyne)

## Firms that cite its devices most
- Quanta System Spa: 2 (https://510kreport.com/company/quanta-system)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)
- W.O.M. World of Medicine GmbH: 1 (https://510kreport.com/company/wom-world-of-medicine)
- Wave Form Mfg., Inc.: 1 (https://510kreport.com/company/wave-form-mfg)
- Med-Fibers, Inc.: 1 (https://510kreport.com/company/med-fibers)
- Optical Integrity, Inc.: 1 (https://510kreport.com/company/optical-integrity)
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Its most-cited devices
- K050108: Sureflex and Accuflex Laser Lithotripsy Fibers (2005), cited by 7
- K994010: Innovaquartz General Shape Laser Fiber (1999), cited by 5
- K142638: ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) (2014), cited by 2
- K203799: ProFlex CO2 Laser Fiber (2021), cited by 1

## Recent decisions
- K233157: VaporMAX LDD; MOJo LDD; MegaJOULE LDD (May 3, 2024)
- K203799: ProFlex CO2 Laser Fiber (Sep 20, 2021)
- K180140: ProFlex Laser Fibers (Apr 20, 2018)
- K142638: ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) (Dec 19, 2014)
- K050108: Sureflex and Accuflex Laser Lithotripsy Fibers (Mar 14, 2005)
- K994010: Innovaquartz General Shape Laser Fiber (Dec 17, 1999)

Source page: https://510kreport.com/company/innovaquartz