Cleared Traditional

K853063 - SMARTKNIFE SYSTEM

K853063 is the FDA 510(k) clearance for SMARTKNIFE SYSTEM by CooperVision, Inc.. It is a Class 1 Ophthalmic device (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.

View all CooperVision, Inc. devices

Submission Details

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.

Device Classification

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 20
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K853063.
RUBY & SAPPHIRE BLADE HOLDER
K861748 · Keeler Instruments, Inc. · Jun 1986
STORZ E9050 & E9055 DIAMOND KNIVES
K861732 · Storz Instrument Co. · May 1986
STORZ E9040 & E9046 DIAMOND KNIVES
K855050 · Storz Instrument Co. · Mar 1986
STORZ DIAMOND KNIFE
K853403 · Storz Instrument Co. · Nov 1985
37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN
K851790 · Artiberia · May 1985
CATARACT TRAY
K842647 · Deroyal Industries, Inc. · May 1985