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Endo-Lase CD40 For Otorhinolaryngology

by Endo Lase, Inc.

510(k) K853902

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853902 Date9 Jan 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EWG
Device Class
Class II
Regulation
21 CFR Part 874.4500
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Endo-Lase Cd40 For Otorhinolaryngology is an ear, nose, and throat microsurgical carbon dioxide laser. It is a device used for the surgical excision of tissue from the ear, nose, and throat. The device is classified as a Laser, Ent Microsurgical Carbon-Dioxide device. It falls under the medical specialty description of Ear, Nose, Throat.

The device is supplied by Endo Lase, Inc. and has been assigned the product code EWG. It has been cleared by the FDA with the k number K853902. The device is intended for use in otorhinolaryngology and is classified under the regulation number 874.4500. The device is a class 2 device.

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Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Endo-Lase Cd40 used for?

    The Endo-Lase Cd40 is used for the surgical excision of tissue from the ear, nose, and throat, specifically in otorhinolaryngology.

  • Is the Endo-Lase Cd40 a single-use device?

    The device data does not specify if the Endo-Lase Cd40 is single-use or reusable, but it is classified as a class 2 device.

  • What is the regulatory classification of the Endo-Lase Cd40?

    The Endo-Lase Cd40 is classified under the regulation number 874.4500 and has been cleared by the FDA with the k number K853902.