Cleared Traditional

XTAL X-800 SHADOWGRAPH (K861163) - FDA 510(k) Clearance

K861163 · Xtal Corp. · Ophthalmic device
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May 1986
Decision
39d
Days
-
Risk

K861163 is an FDA 510(k) clearance for the XTAL X-800 SHADOWGRAPH.

Submitted by Xtal Corp. (Solana Beach, US). The FDA issued a Cleared decision on May 6, 1986 after a review of 39 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 Xtal Corp. devices

Submission Details

510(k) Number K861163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date May 06, 1986
Days to Decision 39 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 110d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -