Ultravision Visual Field Clearing System

Surgical Smoke Precipitator

Alesi Surgical Ltd.

The following data is part of a premarket notification filed by Alesi Surgical Ltd. with the FDA for Ultravision Visual Field Clearing System.

Pre-market Notification Details

Device IDK200035
510k NumberK200035
Device Name:Ultravision Visual Field Clearing System
ClassificationSurgical Smoke Precipitator
Applicant Alesi Surgical Ltd. Cardiff Medicentre, Heath Park Cardiff,  GB Cf14 4uj
ContactDavid Broderick
CorrespondentMichele Lucey
Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury,  NH  03255
Product CodePQM  
CFR Regulation Number878.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-08
Decision Date2020-05-04

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