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 ID: K182053
• 510k Number: K182053
• Device Name: Ultravision™ Visual Field Clearing System
• Classification: Surgical Smoke Precipitator
• Applicant: Alesi Surgical Ltd. Cardiff MediCentre, HeathPark Cardiff, GB Cf14 4uj
• Contact: David Broderick
• Correspondent: Michele Lucey; Lakeshore Medical Device Consulting, LLC 128 Blye Hill Landing Newbury, NH 03255
• Product Code: PQM
• CFR Regulation Number: 878.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-31
• Decision Date: 2018-09-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05060417680245	K182053	000