Cleared Special

MODIFICATION TO: OCU-FILM TIP COVER (K070534) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K070534 · Reichert, Inc. · Ophthalmic device
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Mar 2007
Decision
29d
Days
Class 2
Risk

K070534 is an FDA 510(k) clearance for the MODIFICATION TO: OCU-FILM TIP COVER. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on March 27, 2007 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Reichert, Inc. devices

Submission Details

510(k) Number K070534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2007
Decision Date March 27, 2007
Days to Decision 29 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HKY Tonometer, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
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.