Cleared Traditional

K940647 - ORBSCAN(TM) KERATOMETER

K940647 is an FDA 510(k) clearance for ORBSCAN(TM) KERATOMETER, manufactured by Orbtek, Inc.. The device is a Class 1 Ophthalmic device with product code HLQ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K940647 · Orbtek, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K940647

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.

HLQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - HLQ Keratoscope, Ac-powered

All 28
Devices cleared under the same product code (HLQ) and FDA review panel - the closest regulatory comparables to K940647.
TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER
K945382 · Expertech Assoc., Inc. · Jan 1995
TOPOGRAPHIC MODELING SYSTEM 2 TMS-2
K944207 · Computed Anatomy, Inc. · Dec 1994
KERATRON CORNEAL TOPOGRAPHER
K944616 · Alliance Medical Marketinig · Nov 1994
EH-270 CORNEAL TOPOGRAPHER
K933556 · Visioptic, Inc. · Nov 1993
CORNEAL TOPOGRAPHY SYSTEM
K923435 · Par Microsystems Corp. · Feb 1993
KERATOREF L60
K922253 · Luneau Ophtalmologie SA · Jun 1992
K940647 · ORBSCAN(TM) KERATOMETER
Download PDF FDA Summary Orbtek, Inc.