Cleared Traditional

K924198 - MODIFIED SITE FIBER OPTIC MODULE

K924198 is an FDA 510(k) clearance for MODIFIED SITE FIBER OPTIC MODULE, manufactured by Chiron Vision Corp.. The device is a Class 2 Ophthalmic device with product code FCT cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K924198 · Chiron Vision Corp. · Ophthalmic device
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Nov 1992
Decision
95d
Days
Class 2
Risk

K924198 is an FDA 510(k) clearance for the MODIFIED SITE FIBER OPTIC MODULE. Classified as Headlight, Fiberoptic Focusing (product code FCT), Class II - Special Controls.

Submitted by Chiron Vision Corp. (Horsham, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4335 - 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 Chiron Vision Corp. devices

FDA 510(k) Submission Details - K924198

510(k) Number K924198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1992
Decision Date November 23, 1992
Days to Decision 95 days
Submission Type Traditional
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
15d faster than avg
Panel avg: 110d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCT Device Classification - Class 2, Special Controls

Product Code FCT Headlight, Fiberoptic Focusing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4335
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - FCT Headlight, Fiberoptic Focusing

Devices cleared under the same product code (FCT) and FDA review panel - the closest regulatory comparables to K924198.
LIGHT COMMANDER
K960767 · Scieran Technologies, Inc. · Aug 1996
MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
K883480 · Site Microsurgical Systems, Inc. · Aug 1988
FIBER OPTIC HEADLIGHT #60-0765
K802769 · Aspen Laboratories, Inc. · Dec 1980
FIBER OPTIC HEADLIGHT #60-0766766
K802770 · Aspen Laboratories, Inc. · Dec 1980