Cleared Traditional

K841430 - LASERSPEC (FDA 510(k) Clearance)

K841430 · Clement Clarke, Inc. · Ophthalmic device
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Dec 1984
Decision
251d
Days
-
Risk

K841430 is an FDA 510(k) clearance for the LASERSPEC.

Submitted by Clement Clarke, Inc. (Reynoldsburg, US). The FDA issued a Cleared decision on December 13, 1984 after a review of 251 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 Clement Clarke, Inc. devices

Submission Details

510(k) Number K841430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1984
Decision Date December 13, 1984
Days to Decision 251 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 110d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -