Cleared Special

MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE (K101782) - FDA 510(k) Clearance

Class I Ophthalmic device.

K101782 · Staar Japan · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
180d
Days
Class 1
Risk

K101782 is an FDA 510(k) clearance for the MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE. Classified as Folders And Injectors, Intraocular Lens (iol) (product code MSS), Class I - General Controls.

Submitted by Staar Japan (Monrovia, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 180 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Staar Japan devices

Submission Details

510(k) Number K101782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2010
Decision Date December 22, 2010
Days to Decision 180 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 110d · This submission: 180d
Pathway characteristics
Modification to existing cleared device.

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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