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INNOVAQUARTZ LLC

US

Last updated September 17, 2026

What INNOVAQUARTZ LLC makes

InnovaQuartz LLC manufactures reusable beam guides for general/multiple surgical laser systems, designed to direct laser energy during procedures. These guides are intended for use across various surgical applications requiring precise laser delivery.

The company’s products fall under FDA Class II devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does InnovaQuartz LLC manufacture?

InnovaQuartz LLC specializes in reusable beam guides for general/multiple surgical laser systems. These devices are designed to direct laser energy with precision during surgical procedures, enabling accurate and controlled laser delivery across various applications.

Where is InnovaQuartz LLC based?

InnovaQuartz LLC is headquartered in the United States. The company’s location is relevant for regulatory and operational purposes, particularly when assessing compliance with U.S. medical device regulations.

Which regulatory registries or databases list InnovaQuartz LLC’s devices?

InnovaQuartz LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details.

How are InnovaQuartz LLC’s devices classified by regulatory authorities?

InnovaQuartz LLC’s devices fall under FDA Class II classification. This classification indicates a moderate level of risk, requiring specific regulatory controls to ensure safety and effectiveness while balancing innovation and accessibility in surgical laser applications.

What is the primary purpose of InnovaQuartz LLC’s reusable beam guides?

The reusable beam guides manufactured by InnovaQuartz LLC are intended to enhance precision during surgical procedures by directing laser energy efficiently. Their design supports versatility across multiple surgical laser systems, ensuring compatibility and reliability in clinical settings.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
23030 N 15TH AVE, Phoenix, AZ, 85027
Website
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LinkedIn
—
Facebook
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Email
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3010933841
DUNS Number
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Catalogue (118)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
ProFlex LRU200PF
FDA UDI
Class IIActive
ProFlex™ Reusable 910 Laser Lithotripsy Fiber var. Trimedyne
FDA UDI
Class IIActive
ProFlex™ Laser Lithotripsy Fiber
FDA UDI
Class IIUnknown
ProFlex™ Reusable 200 Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ 273 Single-Use Laser Lithotripsy Fiber var. Trimedyne
FDA UDI
Class IIActive
ProFlex™ Single Use 365 Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ Single Use 273 Laser Lithotripsy Fiber var. SPY Trimedyne
FDA UDI
Class IIActive
ProFlex LSU273PF
FDA UDI
Class IIActive
ProFlex™ Single Use 200 Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ Reusable 550 Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ 200 Single-Use Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ Single Use 150 Laser Lithotripsy Fiber var. SPY
FDA UDI
Class IIActive
ProFlex™ Single Use 365 Laser Lithotripsy Fiber var. Trimedyne
FDA UDI
Class IIActive
ProFlex™ Reusable 273 Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ Single Use 273 Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ 273 Reusable Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ Single Use 550 Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ Laser Lithotripsy Fiber
FDA UDI
Class IIUnknown
ProFlex™ 273 Single-Use Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ Laser Lithotripsy Fiber
FDA UDI
Class IIUnknown
ProFlex™ Reusable 150 Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex SU1000PF
FDA UDI
Class IIActive
Dornier Thulio Performance Fiber 200um Reusable Fiber
FDA UDI
Class IIActive
ProFlex TRU1000PF
FDA UDI
Class IIActive
ProFlex™ Laser Lithotripsy Fiber
FDA UDI
Class IIUnknown
ProFlex™ 550 Single-Use Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ 550 Reusable Laser Lithotripsy Fiber var. Trimedyne
FDA UDI
Class IIActive
ProFlex TSU273PF
FDA UDI
Class IIActive
ProFlex™ Single Use 273 Laser Lithotripsy Fiber var. ProTrac
FDA UDI
Class IIActive
ProFlex™ Laser Lithotripsy Fiber
FDA UDI
Class IIUnknown
ProFlex TSU550PF
FDA UDI
Class IIActive
ProFlex™ 365 Reusable Laser Lithotripsy Fiber var. Trimedyne
FDA UDI
Class IIActive
ProFlex TRU365PF
FDA UDI
Class IIActive
ProFlex LSU200PT
FDA UDI
Class IIActive
ProFlex™ 910 Single-Use Laser Lithotripsy Fiber var. Trimedyne
FDA UDI
Class IIActive
ProFlex RU365PF
FDA UDI
Class IIActive
ProFlex LSU273PT
FDA UDI
Class IIActive
ProFlex RU550PF
FDA UDI
Class IIActive
ProFlex™ Single Use 910 Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ Laser Lithotripsy Fiber
FDA UDI
Class IIUnknown
ProFlex DRU273PF
FDA UDI
Class IIActive
ProFlex™ 910 Reusable Laser Lithotripsy Fiber var. Trimedyne
FDA UDI
Class IIActive
ProFlex™ Reusable 273 Laser Lithotripsy Fiber var. Trimedyne
FDA UDI
Class IIActive
ProFlex™ Laser Lithotripsy Fiber
FDA UDI
Class IIUnknown
ProFlex DSU273PF
FDA UDI
Class IIActive
ProFlex™ Single Use 365 Laser Fiber var. Aurora™
FDA UDI
Class IIActive
ProFlex DSU200PF
FDA UDI
Class IIActive
ProFlex™ 273 Reusable Laser Lithotripsy Fiber
FDA UDI
Class IIActive
ProFlex™ Reusable 550 Laser Fiber var. Aurora™
FDA UDI
Class IIActive
ProFlex TRU200PF
FDA UDI
Class IIActive

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