Cleared Traditional

K101134 - VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 (FDA 510(k) Clearance)

Class I Ophthalmic device.

K101134 · Medicel AG · Ophthalmic device
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Aug 2010
Decision
109d
Days
Class 1
Risk

K101134 is an FDA 510(k) clearance for the VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Medicel AG (Monrovia, US). The FDA issued a Cleared decision on August 9, 2010 after a review of 109 days - within the typical 510(k) review window.

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 Medicel AG devices

Submission Details

510(k) Number K101134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2010
Decision Date August 09, 2010
Days to Decision 109 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
1d faster than avg
Panel avg: 110d · This submission: 109d
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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