Cleared Traditional

K841730 - BAILEY LENS SHOOTER

K841730 is an FDA 510(k) clearance for BAILEY LENS SHOOTER, manufactured by Intermedics Intraocular, Inc.. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K841730 · Intermedics Intraocular, Inc. · Ophthalmic device
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Nov 1984
Decision
208d
Days
Class 1
Risk

K841730 is an FDA 510(k) clearance for the BAILEY LENS SHOOTER. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Intermedics Intraocular, Inc. (Freeport, US). The FDA issued a Cleared decision on November 19, 1984 after a review of 208 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 Intermedics Intraocular, Inc. devices

FDA 510(k) Submission Details - K841730

510(k) Number K841730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1984
Decision Date November 19, 1984
Days to Decision 208 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 110d · This submission: 208d
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 K841730.
ELASTIC LENS INJECTOR TM
K861085 · Staar Surgical Co. · May 1986
MAZZOCCO/FRENCHIK FOLDER
K860148 · Staar Surgical Co. · Mar 1986
IOSERT LENS IMPLANT INSTRUMENT
K854197 · Chiron Vision Corp. · Jan 1986
INTRAOCULAR LENS GUIDE
K823222 · American Medical Optics · Dec 1982
SURFACE REPLACEMENT HIP PROSTHESIS
K811718 · Biomet, Inc. · Sep 1981
CEMENT SPACERS
K791351 · Depuy, Inc. · Aug 1979