Cleared Traditional

K834539 - AXIPAC II (FDA 510(k) Clearance)

K834539 · Teknar, Inc. · Ophthalmic device
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Sep 1984
Decision
272d
Days
-
Risk

K834539 is an FDA 510(k) clearance for the AXIPAC II.

Submitted by Teknar, Inc. (Walker, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 272 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Teknar, Inc. devices

Submission Details

510(k) Number K834539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date September 11, 1984
Days to Decision 272 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 110d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -