Cleared Traditional

K840115 - SWISS OPTICAL PRODUCTS-CONTACT CASE

K840115 is an FDA 510(k) clearance for SWISS OPTICAL PRODUCTS-CONTACT CASE, manufactured by Moonbeam International, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K840115 · Moonbeam International, Inc. · Ophthalmic device
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Jun 1984
Decision
142d
Days
Class 2
Risk

K840115 is an FDA 510(k) clearance for the SWISS OPTICAL PRODUCTS-CONTACT CASE. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Moonbeam International, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1984 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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 Moonbeam International, Inc. devices

FDA 510(k) Submission Details - K840115

510(k) Number K840115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1984
Decision Date June 01, 1984
Days to Decision 142 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 110d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.