Cleared Traditional

K170178 - Ultravision Visual Field Clearing System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
1d faster than avg
Panel avg: 128d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.