Cleared Traditional

K941550 - AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT

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

K941550 · Chiron Vision Corp. · Ophthalmic device
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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

FDA 510(k) Submission Details - K941550

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.

HNO Device Classification - Class 1, General Controls

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 57
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K941550.
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
K970377 · Plancon Instruments · Mar 1997
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K962661 · Med-Logics, Inc. · Dec 1996
PLANCON MIRCOLAMELLAR KERATOME
K960395 · Plancon Instruments · Apr 1996
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