Cleared Traditional

K812015 - GLAUKON (FDA 510(k) Clearance)

K812015 · Sonometrics Systems, Inc. · Ophthalmic device
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Feb 1982
Decision
206d
Days
-
Risk

K812015 is an FDA 510(k) clearance for the GLAUKON.

Submitted by Sonometrics Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1982 after a review of 206 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 Sonometrics Systems, Inc. devices

Submission Details

510(k) Number K812015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1981
Decision Date February 08, 1982
Days to Decision 206 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 110d · This submission: 206d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -