Cleared Traditional

K170178 - Ultravision Visual Field Clearing System

K170178 is an FDA 510(k) clearance for Ultravision Visual Field Clearing System, manufactured by Alesi Surgical, Ltd.. The device is a Class 2 General Hospital device with product code PQM cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K170178 · Alesi Surgical, Ltd. · General Hospital
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May 2017
Decision
127d
Days
Class 2
Risk

K170178 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 May 26, 2017 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5050 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Alesi Surgical, Ltd. devices

FDA 510(k) Submission Details - K170178

510(k) Number K170178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2017
Decision Date May 26, 2017
Days to Decision 127 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PQM Device Classification - Class 2, Special Controls

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.