Cleared Traditional

K970727 - MPORT FOLDABLE LENS PLACEMENT SYSTEM

K970727 is the FDA 510(k) clearance for MPORT FOLDABLE LENS PLACEMENT SYSTEM by Chiron Vision Corp.. It is a Class 1 Ophthalmic device (product code MSS) cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K970727 · Chiron Vision Corp. · Ophthalmic device
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Dec 1997
Decision
292d
Days
Class 1
Risk

K970727 is an FDA 510(k) clearance for the MPORT FOLDABLE LENS PLACEMENT SYSTEM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Chiron Vision Corp. (Claremont, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 292 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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 Chiron Vision Corp. devices

Submission Details

510(k) Number K970727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1997
Decision Date December 17, 1997
Days to Decision 292 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 110d · This submission: 292d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSS Folders And Injectors, Intraocular Lens (iol)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
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.