Cleared Traditional

RHODA-LUX LENS BLANKS (K850909) - FDA 510(k) Clearance

K850909 · Optatint, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
213d
Days
-
Risk

K850909 is an FDA 510(k) clearance for the RHODA-LUX LENS BLANKS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Optatint, Inc. (Englewood, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 213 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 Optatint, Inc. devices

Submission Details

510(k) Number K850909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date October 04, 1985
Days to Decision 213 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 110d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -