Cleared Traditional

K940593 - DISPOSABLE MICROSTAAR INJECTOR

K940593 is an FDA 510(k) clearance for DISPOSABLE MICROSTAAR INJECTOR, manufactured by Staar Sugical. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K940593 · Staar Sugical · Ophthalmic device
Download Printable Device Report (PDF)
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Sep 1994
Decision
222d
Days
Class 1
Risk

K940593 is an FDA 510(k) clearance for the DISPOSABLE MICROSTAAR INJECTOR. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Staar Sugical (Monrovia, US). The FDA issued a Cleared decision on September 19, 1994 after a review of 222 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. 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 Staar Sugical devices

FDA 510(k) Submission Details - K940593

510(k) Number K940593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1994
Decision Date September 19, 1994
Days to Decision 222 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
112d slower than avg
Panel avg: 110d · This submission: 222d
Pathway characteristics
Predicate-based equivalence.

KYB Device Classification - Class 1, General Controls

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.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 24
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K940593.
AMO PHACOFLEX II INTERSECTION SYSTEM
K961242 · Allergan, Inc. · Jun 1996
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
K954600 · Staar Surgical Co. · Dec 1995
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K951292 · Chiron Vision Corp. · Jun 1995
KRATZ NOVA-SERT
K871440 · CooperVision, Inc. · May 1987
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
K870265 · CooperVision, Inc. · Feb 1987
SOFT LENS FOLDER
K861990 · Staar Surgical Co. · Jun 1986