Cleared Traditional

XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM (K082871) - FDA 510(k) Clearance

Class I Ophthalmic device.

K082871 · Sis Ltd., Surgical Instrument Systems · Ophthalmic device
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Jul 2009
Decision
283d
Days
Class 1
Risk

K082871 is an FDA 510(k) clearance for the XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Sis Ltd., Surgical Instrument Systems (Greenwood Village, US). The FDA issued a Cleared decision on July 9, 2009 after a review of 283 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 Sis Ltd., Surgical Instrument Systems devices

Submission Details

510(k) Number K082871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date July 09, 2009
Days to Decision 283 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 110d · This submission: 283d
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.

Regulatory Peers - MSS Folders And Injectors, Intraocular Lens (iol)

All 61
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