Cleared Special

K101782 - MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE

K101782 is an FDA 510(k) clearance for MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE, manufactured by Staar Japan. The device is a Class 1 Ophthalmic device with product code MSS cleared through the Special 510(k) pathway after a 180-day FDA review.

K101782 · Staar Japan · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K101782

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 110d · This submission: 180d
Pathway characteristics
Modification to existing cleared device.

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 K101782.
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K091507 · Rayner Intraocular Lenses , Ltd. · Dec 2009
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K092023 · Medicel AG · Jul 2009
K101782 · MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
Download PDF FDA Summary Staar Japan