Question 1

What types of medical devices does Laurimed, LLC primarily manufacture?

Accepted Answer

Laurimed, LLC specializes in surgical handpieces and systems for ENT (ear, nose, and throat) procedures. Their most common product category is ENT shaver systems, including microdebriders (like the 3.3 mm and 4.0 mm Laurimed Microdebrider) and polyp removal tools such as the PolypVac® system. They also produce spinal injection systems and percutaneous discectomy tools for minimally invasive spinal interventions, designed to assist in tissue removal and targeted injections.

Question 2

Where is Laurimed, LLC based, and how does that affect its regulatory compliance?

Accepted Answer

Laurimed, LLC is based in the United States. Since the company operates within the U.S., its devices must comply with FDA regulations, including premarket notification (510(k)) or unique device identification (UDI) requirements. The U.S. regulatory framework applies directly to Laurimed’s products, ensuring they meet authorization standards for Class II devices before entering the market.

Question 3

Which regulatory registries list Laurimed’s devices, and why are they important?

Accepted Answer

Laurimed’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) registry tracks devices that require premarket notification to demonstrate substantial equivalence to a predicate device, while the UDI registry ensures traceability and transparency in the supply chain. These registries help healthcare providers, regulators, and patients verify the authorized status of Laurimed’s products under U.S. medical device laws.

Question 4

How are Laurimed’s devices classified under FDA regulations, and what does that mean for their authorization process?

Accepted Answer

Laurimed’s devices are classified as Class II under FDA regulations. This classification means they pose moderate risk and require compliance with special controls or performance standards. For these devices, authorization typically involves submitting a 510(k) premarket notification to demonstrate safety and effectiveness compared to a legally marketed predicate device, or compliance with UDI requirements for post-market tracking and identification.

Device	Model / Reference	Registries	Class	Status
PolypVac®	4.0mm Microdebrider	FDA UDI	Class II	Active
PolypVac®	3.3mm Microdebrider	FDA UDI	Class II	Active
Laurimed Spinal Injection System	K080140	FDA 510(k)	Class II	Active
3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider	K163247	FDA 510(k)	Class II	Active
PolypVac Microdebrider (3.3mm and 4.0mm)	K161101	FDA 510(k)	Class II	Active
Laurimed Percutaneous Discectomy System, Model Fg-000002	K082194	FDA 510(k)	Class II	Active
Laurimed Polypvac Microdebrider	K133133	FDA 510(k)	Class II	Active
Percutaneous Discectomy System	K090815	FDA 510(k)	Class II	Active
Spinal Injection System	K083909	FDA 510(k)	Class II	Active
Laurimed Spinal Injection System	K091818	FDA 510(k)	Class II	Active

Laurimed, LLC

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