Cleared Traditional

K101134 - VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430

K101134 is an FDA 510(k) clearance for VISIAN NANOPOINT 2.0 INJECTOR MODEL LP6..., manufactured by Medicel AG. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Traditional 510(k) pathway after a 109-day FDA review.

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

FDA 510(k) Submission Details - K101134

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.

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 61
Devices cleared under the same product code (MSS) and FDA review panel - the closest regulatory comparables to K101134.
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