Cleared Traditional

K841730 - BAILEY LENS SHOOTER

K841730 is the FDA 510(k) clearance for BAILEY LENS SHOOTER by Intermedics Intraocular, Inc.. It is a Class 1 Ophthalmic device (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

Submission Details

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.

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.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 11
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K841730.
KRATZ NOVA-SERT
K871440 · CooperVision, Inc. · May 1987
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
K870265 · CooperVision, Inc. · Feb 1987
IOSERT LENS IMPLANT INSTRUMENT
K854197 · Chiron Vision Corp. · Jan 1986
SURFACE REPLACEMENT HIP PROSTHESIS
K811718 · Biomet, Inc. · Sep 1981
CEMENT SPACERS
K791351 · Depuy, Inc. · Aug 1979