Cleared Traditional

K082871 - XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM

K082871 is an FDA 510(k) clearance for XACT LENS INSERTER SYSTEM, manufactured by Sis Ltd., Surgical Instrument Systems. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K082871 · Sis Ltd., Surgical Instrument Systems · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K082871

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 110d · This submission: 283d
Pathway characteristics
Predicate-based equivalence.

MSS Device Classification - Class 1, General Controls

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 62
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K082871.
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
K101134 · Medicel AG · Aug 2010
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K091507 · Rayner Intraocular Lenses , Ltd. · Dec 2009
NAVIJECT SUB2-1P, MODEL: LP604430
K092023 · Medicel AG · Jul 2009
EPIPHANY INJECTION SYSTEM
K090161 · Staar Surgical Co. · Jun 2009
HOYA IS INJECTOR SYSTEM
K081346 · Hoya Surgical Optics, Inc. · Mar 2009
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · Bausch & Lomb, Inc. · Oct 2008
K082871 · XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
Download PDF FDA Summary Sis Ltd., Surgical In…