Cleared Traditional

K853063 - SMARTKNIFE SYSTEM

K853063 is an FDA 510(k) clearance for SMARTKNIFE SYSTEM, manufactured by CooperVision, Inc.. The device is a Class 1 Ophthalmic device with product code HNN cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K853063 · CooperVision, Inc. · Ophthalmic device
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Nov 1985
Decision
108d
Days
Class 1
Risk

K853063 is an FDA 510(k) clearance for the SMARTKNIFE SYSTEM. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on November 4, 1985 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K853063

510(k) Number K853063 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 19, 1985
Decision Date November 04, 1985
Days to Decision 108 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 110d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

HNN Device Classification - Class 1, General Controls

Product Code HNN Knife, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HNN Knife, Ophthalmic

All 53
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K853063.
VERSABLADE
K852633 · Alphamedix, Inc. · Nov 1985
VERSABLADE
K852706 · Alphamedix, Inc. · Nov 1985
BEAVER R-K KNIFE
K852828 · Rudolph Beaver, Inc. · Nov 1985
STORZ DIAMOND KNIFE
K853403 · Storz Instrument Co. · Nov 1985
OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE
K853598 · Myocure, Inc. · Nov 1985
MICRON-SCOPE
K853499 · Magnum Diamond, Inc. · Sep 1985
K853063 · SMARTKNIFE SYSTEM
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