Cleared Traditional

K970377 - PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)

K970377 is an FDA 510(k) clearance for PLANCON MICROLAMELLAR KERATOME (SINGLE ..., 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 56-day FDA review.

K970377 · Plancon Instruments · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
56d
Days
Class 1
Risk

K970377 is an FDA 510(k) clearance for the PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES). 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 March 31, 1997 after a review of 56 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 - K970377

510(k) Number K970377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date March 31, 1997
Days to Decision 56 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
54d faster than avg
Panel avg: 110d · This submission: 56d
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 41
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K970377.
HANSATOME MICROKERATOME
K972808 · Chiron Vision Corp. · Oct 1997
CBALK-1000 BLADE
K972727 · Howard Instruments, Inc. · Oct 1997
INNOVATOME MICROKERATOME
K973294 · Innovative Optics, Inc. · Oct 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