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LAPEX BCS

by Meridian Co., Ltd.

510(k) K081962

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 NumberK081962 Date29 Dec 2008ClearedStatusActive

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  • Withdrawn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
ILY
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 LAPEX BCS is a device classified under the product code ILY, which corresponds to a physical medicine device. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.

The device was manufactured by Meridian Co., Ltd. and received FDA 510(k) clearance under K081962 on December 29, 2008. It is authorized for distribution in the United States and is identified by the applicant and manufacturer as Meridian Co., Ltd. with an address in Deer Field, IL.

Other devices from Meridian AG

See all devices from Meridian AG →

Questions

AI-generated answers, 23 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 LAPEX BCS device used for?

    The LAPEX BCS is classified under product code ILY, which corresponds to a physical medicine device, indicating its use in physical medicine applications as determined by its FDA 510(k) clearance.

  • Who manufactures the LAPEX BCS and where are they located?

    The LAPEX BCS is manufactured by Meridian Co., Ltd., with their address listed as P.O. Box 7007, Deer Field, IL 60015, United States, as recorded in the FDA 510(k) submission.

  • What regulatory pathway was used for the LAPEX BCS clearance?

    The LAPEX BCS received FDA 510(k) clearance through a traditional 510(k) process, determined to be substantially equivalent to a predicate device under decision code SESE.

  • When was the LAPEX BCS cleared by the FDA and under what k-number?

    The LAPEX BCS was cleared by the FDA on December 29, 2008, under k-number K081962, following submission on July 9, 2008, and is authorized for distribution in the United States.