Argon Microsurgical Protocols
FDA 510(k)Class II (US FDA 510(k))
by Lumenis Inc.
Identifiers
- 510(k) Number
- K810740 FDA 510(k)
- FDA Product Code
- EWG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4500 FDA 510(k)
- Regulation Number
- 874.4500 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Argon Microsurgical Protocols is an ENT microsurgical laser device. It is designed to perform surgical procedures within the ear, nose, and throat medical specialty.
This device is classified as a Class 2 medical device under regulation number 874.4500. It has received FDA 510(k) clearance, identified by K810740.
Frequently asked questions
What is the intended use of the Argon Microsurgical Protocols?
This device is an ENT microsurgical laser designed specifically for performing surgical procedures within the ear, nose, and throat medical specialty.
What is the regulatory classification of this device?
The Argon Microsurgical Protocols is classified as a Class 2 medical device under regulation number 874.4500 and has received FDA 510(k) clearance under K810740.
Who is the manufacturer of this microsurgical laser?
The device is manufactured by Lumenis, Inc., which is located in McHenry, Illinois.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ARGON MICROSURIGAL PROTOCOLS (K810740) — FDA 510(k) | Innolitics, ARGON MICROSURIGAL PROTOCOLS 510 (k) K810740 - FDA.report, PDF K810740 - Argon Microsurigal Protocols, Product code EWG — ARGON MICROSURIGA… · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K810740 | Class II | Active |
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Manufacturer
- Manufacturer
- Lumenis Inc.
- FDA Applicant
- Lumenis, Inc.
Sources (1)
- FDA 510(k) K810740 24 fields · synced Sep 22, 2026