Cleared Traditional

VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR

K981821 · Angiolaz, Inc. · General & Plastic Surgery
Jul 1998
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K981821 is an FDA 510(k) clearance for the VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR, a Light, Surgical, Floor Standing (Class II — Special Controls, product code FSS), submitted by Angiolaz, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on July 29, 1998, 68 days after receiving the submission on May 22, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K981821 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1998
Decision Date July 29, 1998
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FSS — Light, Surgical, Floor Standing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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