Cleared Traditional

OPHTHALMIC PROJECTOR (K921214) - FDA 510(k) Clearance

Class I Ophthalmic device.

K921214 · Luneau Ophtalmologie SA · Ophthalmic device
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Jun 1992
Decision
90d
Days
Class 1
Risk

K921214 is an FDA 510(k) clearance for the OPHTHALMIC PROJECTOR. Classified as Projector, Ophthalmic (product code HOS), Class I - General Controls.

Submitted by Luneau Ophtalmologie SA (Chartres Cedex, FR). The FDA issued a Cleared decision on June 11, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1680 - 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 Luneau Ophtalmologie SA devices

Submission Details

510(k) Number K921214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date June 11, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOS Projector, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1680
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.