Cleared Special

K182053 - Ultravision™ Visual Field Clearing System (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182053 · Alesi Surgical, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
38d
Days
Class 2
Risk

K182053 is an FDA 510(k) clearance for the Ultravision™ Visual Field Clearing System. Classified as Surgical Smoke Precipitator (product code PQM), Class II - Special Controls.

Submitted by Alesi Surgical, Ltd. (Cardiff, GB). The FDA issued a Cleared decision on September 7, 2018 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5050 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alesi Surgical, Ltd. devices

Submission Details

510(k) Number K182053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2018
Decision Date September 07, 2018
Days to Decision 38 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 128d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PQM Surgical Smoke Precipitator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5050
Definition The Device Is Intended To Precipitate Surgical Smoke To Allow Surgeons Adequately Visualize Laparoscopic Surgeries In The Using Surgical Smoke/aerosolized Particulate Surgical Tools.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.