Cleared Traditional

K883480 - MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE

K883480 is an FDA 510(k) clearance for MODIFIED SITE FIBER OPTIC MODULE FOR OP..., manufactured by Site Microsurgical Systems, Inc.. The device is a Class 2 Ophthalmic device with product code FCT cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K883480 · Site Microsurgical Systems, Inc. · Ophthalmic device
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Aug 1988
Decision
8d
Days
Class 2
Risk

K883480 is an FDA 510(k) clearance for the MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE. Classified as Headlight, Fiberoptic Focusing (product code FCT), Class II - Special Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on August 24, 1988 after a review of 8 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K883480

510(k) Number K883480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date August 24, 1988
Days to Decision 8 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 110d · This submission: 8d
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 K883480.
LIGHT COMMANDER
K960767 · Scieran Technologies, Inc. · Aug 1996
MODIFIED SITE FIBER OPTIC MODULE
K924198 · Chiron Vision Corp. · Nov 1992
FIBER OPTIC HEADLIGHT #60-0765
K802769 · Aspen Laboratories, Inc. · Dec 1980
FIBER OPTIC HEADLIGHT #60-0766766
K802770 · Aspen Laboratories, Inc. · Dec 1980
FIBER OPTIC ADJUSTABLE HEADLIGHT
K780433 · Cameron-Miller, Inc. · Jun 1978
K883480 · MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
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