Cleared Traditional

ORBSCAN(TM) KERATOMETER (K940647) - FDA 510(k) Clearance

Class I Ophthalmic device.

K940647 · Orbtek, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
141d
Days
Class 1
Risk

K940647 is an FDA 510(k) clearance for the ORBSCAN(TM) KERATOMETER. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Orbtek, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 6, 1994 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - 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 Orbtek, Inc. devices

Submission Details

510(k) Number K940647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1994
Decision Date July 06, 1994
Days to Decision 141 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 110d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLQ Keratoscope, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
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.