Cleared Traditional

SUN BED BY VERRE ET QUARTZ UVA-FRANCE (K833229) - FDA 510(k) Clearance

Class I Ophthalmic device.

K833229 · H & M Douglas Enterprises, Inc. · Ophthalmic device
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Jan 1984
Decision
156d
Days
Class 1
Risk

K833229 is an FDA 510(k) clearance for the SUN BED BY VERRE ET QUARTZ UVA-FRANCE. Classified as Locator, Magnetic (product code FTZ), Class I - General Controls.

Submitted by H & M Douglas Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 156 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4445 - 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 H & M Douglas Enterprises, Inc. devices

Submission Details

510(k) Number K833229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1983
Decision Date January 27, 1984
Days to Decision 156 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 110d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FTZ Locator, Magnetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4445
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.