Cleared Traditional

K843957 - ULTRATHIN/SP LENS

K843957 is an FDA 510(k) clearance for ULTRATHIN/SP LENS, manufactured by Optical Systems Intl., Inc.. The device is a Class 1 Ophthalmic device with product code HRG cleared through the Traditional 510(k) pathway after a 294-day FDA review.

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

FDA 510(k) Submission Details - K843957

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.

HRG Device Classification - Class 1, General Controls

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.