Cleared Traditional

DEXSOL (K883854) - FDA 510(k) Clearance

K883854 · Northern Scientific, Inc. · Ophthalmic device
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Nov 1988
Decision
64d
Days
-
Risk

K883854 is an FDA 510(k) clearance for the DEXSOL. Classified as Media, Corneal Storage (product code LYX).

Submitted by Northern Scientific, Inc. (Buffalo, US). The FDA issued a Cleared decision on November 16, 1988 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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 Northern Scientific, Inc. devices

Submission Details

510(k) Number K883854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date November 16, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 110d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -