Cleared Traditional

K842835 - BRILLETTE MODEL

K842835 is an FDA 510(k) clearance for BRILLETTE MODEL, manufactured by Cillus Company, Inc.. The device is a Class 1 Ophthalmic device with product code HOI cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K842835 · Cillus Company, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
124d
Days
Class 1
Risk

K842835 is an FDA 510(k) clearance for the BRILLETTE MODEL. Classified as Spectacle, Magnifying (product code HOI), Class I - General Controls.

Submitted by Cillus Company, Inc. (Novato, US). The FDA issued a Cleared decision on November 21, 1984 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5840 - the FDA ophthalmic device framework. 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 Cillus Company, Inc. devices

FDA 510(k) Submission Details - K842835

510(k) Number K842835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date November 21, 1984
Days to Decision 124 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 110d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

HOI Device Classification - Class 1, General Controls

Product Code HOI Spectacle, Magnifying
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5840
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.