Cleared Traditional

ULTRATHIN/SP LENS (K843957) - FDA 510(k) Clearance

Class I Ophthalmic device.

K843957 · Optical Systems Intl., Inc. · Ophthalmic device
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Jul 1985
Decision
294d
Days
Class 1
Risk

K843957 is an FDA 510(k) clearance for the ULTRATHIN/SP LENS. Classified as Engine, Trephine, Accessories, Ac-powered (product code HRG), Class I - General Controls.

Submitted by Optical Systems Intl., Inc. (Hialeah, US). The FDA issued a Cleared decision on July 31, 1985 after a review of 294 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4070 - 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 Optical Systems Intl., Inc. devices

Submission Details

510(k) Number K843957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1984
Decision Date July 31, 1985
Days to Decision 294 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 110d · This submission: 294d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRG Engine, Trephine, Accessories, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4070
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.