Skip to content

Klarity

by Larson Products, Inc.

510(k) K022708

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022708 Date12 Nov 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Klarity is a medical linear accelerator device used in the field of radiology. It is classified as a medical linear accelerator under regulation number 892.5050.

This device is authorized via FDA 510K clearance. It is manufactured by Larson Products, Inc.

Questions

AI-generated answers, 26 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 primary use of the Klarity device?

    Klarity is a medical linear accelerator designed for use in the field of radiology. It is categorized under regulation number 892.5050.

  • Is the Klarity device authorized for clinical use?

    Yes, the Klarity device is authorized for use through FDA 510K clearance, which indicates it has been reviewed and cleared by the FDA.

  • Who is the manufacturer of the Klarity linear accelerator?

    The Klarity device is manufactured by Larson Products, Inc., located in Columbus, Ohio.