Skip to content

Model 20-C W/Br-20A/U Attach/Model Hl-3.O Attach

by Directed Energy, Inc. 510(k)

Active United States

510(k) K870840

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870840 Date12 Jun 1987ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

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

Other devices from Directed Energy, Inc.

See all devices from Directed Energy, Inc. →