Question 1

What types of medical devices does Lazurite Holdings LLC manufacture?

Accepted Answer

Lazurite Holdings LLC specialises in components and kits for surgical video camera and microscope systems. Their devices include battery chargers, receiver units, wireless camera heads, and sterilisation trays, often packaged as modular kits for operating room use. For example, they produce the ArthroFree Battery Charger Kit and Wireless Camera Head, which are designed for arthroscopic procedures.

Question 2

Where is Lazurite Holdings LLC based?

Accepted Answer

Lazurite Holdings LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and device authorisation processes, particularly when navigating FDA requirements.

Question 3

Which regulatory registries list Lazurite Holdings LLC’s devices?

Accepted Answer

Lazurite Holdings LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries track authorised medical devices in the US, ensuring transparency and compliance with regulatory standards.

Question 4

How are Lazurite Holdings LLC’s devices classified under FDA regulations?

Accepted Answer

Lazurite Holdings LLC’s devices fall under Class II classification, which applies to medical devices posing moderate risk. This classification requires premarket notification (510(k)) or other regulatory pathways to demonstrate safety and effectiveness before authorisation.

Device	Model / Reference	Registries	Class	Status
Lazurite Holdings LLC ArthroFree Battery Charger Kit	AF0029-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC ArthroFree Receiver Kit	AF0028-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC ArthroFree Operating Room Kit	AF0013-101-11	FDA UDI	Class II	Active
Lazurite Holdings LLC ArthroFree Sterilization Tray Kit	AF0030-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC ArthroFree Additional Camera Kit	AF0014-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC Sterilization Tray	AF0005-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC Wireless Camera Head	AF0001-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC Receiver	AF0002-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC ArthroFree Sterilization Tray Kit	AF0030-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC Battery Charger	AF0004-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC ArthroFree Battery Set	AF0015-101-10	FDA UDI	Class II	Active
Lazurite Holdings LLC Battery	AF0003-101-10	FDA UDI	Class II	Active
ArthroFree Wireless Surgical Camera System	K213860	FDA 510(k)	Class II	Active

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