Cleared Traditional

MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE (K883480) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Site Microsurgical Systems, Inc. devices

Submission Details

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
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.

Device Classification

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.