Cleared Traditional

ISOLIGHT

K842358 · Planmeca USA, Inc. · Dental
Jul 1984
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K842358 is an FDA 510(k) clearance for the ISOLIGHT, a Light, Surgical Headlight (Class I — General Controls, product code EBA), submitted by Planmeca USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 31, 1984, 39 days after receiving the submission on June 22, 1984. This device falls under the Dental review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number K842358 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1984
Decision Date July 31, 1984
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EBA — Light, Surgical Headlight
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4630

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