Cleared Traditional

K841430 - LASERSPEC

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

FDA 510(k) Submission Details - K841430

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 - Class ,

Product Code -
Device Class -