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CO2 Laser Machine (Lume)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250465

by Nanjing Bestview Laser S&T Co., Ltd.

Identifiers

510(k) Number
K250465 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CO2 Laser Machine (Lume) is a laser device used in general and plastic surgery procedures. It is substantially equivalent to predicate devices as determined by FDA 510(k) clearance.

The device is manufactured by Nanjing Bestview Laser S&T Co., Ltd. and was cleared via the traditional 510(k) pathway under product code GEX. It is supplied as a non-sterile, reusable system intended for use in clinical settings under professional supervision.

Frequently asked questions

What is the CO2 Laser Machine (Lume) used for?

The CO2 Laser Machine (Lume) is used in general and plastic surgery procedures as a laser device for cutting, ablating, or vaporizing tissue under professional supervision in clinical settings.

Is the CO2 Laser Machine (Lume) sterile or non-sterile, and is it reusable?

The CO2 Laser Machine (Lume) is supplied as a non-sterile, reusable system, meaning it must be cleaned and sterilized by the user before each clinical use according to established reprocessing protocols.

How was the CO2 Laser Machine (Lume) cleared for market release?

The CO2 Laser Machine (Lume) received FDA 510(k) clearance through the traditional pathway, demonstrating substantial equivalence to predicate devices under product code GEX for general and plastic surgery applications.

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: CO2 Laser Machine (Lume) (K250465) — FDA 510(k) | Innolitics, K250465 FDA 510 (k) - CO2 Laser Machine (Lume), PDF Nanjing Bestview Laser S&T Co., Ltd. - accessdata.fda.gov, BVLASER Solutions - Nanjing Bestview Laser S&T Co.,Ltd, CO2 Laser Machine (Lume) (K250465) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nanjing Bestview Laser S&T Co., Ltd.

Sources (1)

  • FDA 510(k) K250465 24 fields · synced Sep 28, 2026