Cleared Traditional

K960395 - PLANCON MIRCOLAMELLAR KERATOME

K960395 is an FDA 510(k) clearance for PLANCON MIRCOLAMELLAR KERATOME, manufactured by Plancon Instruments. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K960395 · Plancon Instruments · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
88d
Days
Class 1
Risk

K960395 is an FDA 510(k) clearance for the PLANCON MIRCOLAMELLAR KERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Plancon Instruments (Antony, FR). The FDA issued a Cleared decision on April 26, 1996 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Plancon Instruments devices

FDA 510(k) Submission Details - K960395

510(k) Number K960395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date April 26, 1996
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
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 43
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K960395.
CBALK-1000 BLADE
K972727 · Howard Instruments, Inc. · Oct 1997
INNOVATOME MICROKERATOME
K973294 · Innovative Optics, Inc. · Oct 1997
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
K970377 · Plancon Instruments · Mar 1997
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
K941550 · Chiron Vision Corp. · Nov 1994
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K911062 · Storz Instrument Co. · May 1991
STORZ DRAEGER ROTOR KERATOME
K904845 · Storz Instrument Co. · Jan 1991