Cleared Traditional

MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH

K870840 · Directed Energy, Inc. · Ear, Nose, Throat
Jun 1987
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K870840 is an FDA 510(k) clearance for the MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH, a Laser, Ent Microsurgical Carbon-dioxide (Class II — Special Controls, product code EWG), submitted by Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 12, 1987, 106 days after receiving the submission on February 26, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4500.

Submission Details

510(k) Number K870840 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1987
Decision Date June 12, 1987
Days to Decision 106 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code EWG — Laser, Ent Microsurgical Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.4500

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