Cleared Special

K152357 - MicroSTAAR Injector System Cartridges (FDA 510(k) Clearance)

Class I Ophthalmic device.

K152357 · STAAR Surgical Company · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
71d
Days
Class 1
Risk

K152357 is an FDA 510(k) clearance for the MicroSTAAR Injector System Cartridges. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by STAAR Surgical Company (Monrovia, US). The FDA issued a Cleared decision on October 30, 2015 after a review of 71 days - a notably fast clearance 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. Low regulatory complexity profile. 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 Surgical Company devices

Submission Details

510(k) Number K152357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2015
Decision Date October 30, 2015
Days to Decision 71 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
39d faster than avg
Panel avg: 110d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KYB Lens, Guide, Intraocular
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.