Lympha Press 201MAX, Model 201MAX

by Mego Afek AC, Ltd. 510(k)

Active United States

510(k) K100677

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK100677	Date20 May 2010Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K100677
FDA Product Code: JOW
FDA applicant: Mego Afek AC , Ltd.

Device Class: Class II
Regulation: 21 CFR Part 870.5800
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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