Cleared Traditional

K941550 - AUTOMATIC CORNEAL SHAPER SURGICAL INSTR...

K941550 is the FDA 510(k) clearance for AUTOMATIC CORNEAL SHAPER SURGICAL INSTR... by Chiron Vision Corp.. It is a Class 1 Ophthalmic device (product code HNO) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K941550 · Chiron Vision Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
237d
Days
Class 1
Risk

K941550 is an FDA 510(k) clearance for the AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Chiron Vision Corp. (Horsham, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 237 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4370 - 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 Chiron Vision Corp. devices

Submission Details

510(k) Number K941550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1994
Decision Date November 22, 1994
Days to Decision 237 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 110d · This submission: 237d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNO Keratome, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4370
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 - HNO Keratome, Ac-powered

All 14
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K941550.
HANSATOME MICROKERATOME
K010260 · Bausch & Lomb, Inc. · Apr 2001
MICROKERATOME, MODEL MK-2000
K990900 · Nidek, Inc. · Sep 1999
HANSATOME MICROKERATOME
K972808 · Chiron Vision Corp. · Oct 1997
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · Storz Instrument Co. · May 1991
STORZ DRAEGER ROTOR KERATOME
K904845 · Storz Instrument Co. · Jan 1991
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
K870807 · Allergan, Inc. · May 1987