Cleared Traditional

MODEL XA-15 LASER SYSTEM FOR SURGERY (K837216) - FDA 510(k) Clearance

K837216 · Xanar, Inc. · Radiology device
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Apr 1983
Decision
35d
Days
-
Risk

K837216 is an FDA 510(k) clearance for the MODEL XA-15 LASER SYSTEM FOR SURGERY.

Submitted by Xanar, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on April 4, 1983 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Radiology 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 Xanar, Inc. devices

Submission Details

510(k) Number K837216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1983
Decision Date April 04, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -