Cleared Traditional

K972808 - HANSATOME MICROKERATOME

K972808 is an FDA 510(k) clearance for HANSATOME MICROKERATOME, 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 88-day FDA review.

K972808 · Chiron Vision Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
88d
Days
Class 1
Risk

K972808 is an FDA 510(k) clearance for the HANSATOME MICROKERATOME. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Chiron Vision Corp. (Irvine, US). The FDA issued a Cleared decision on October 24, 1997 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 Chiron Vision Corp. devices

FDA 510(k) Submission Details - K972808

510(k) Number K972808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1997
Decision Date October 24, 1997
Days to Decision 88 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
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 57
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K972808.
MICROKERATOME OR THE MATE
K974598 · Howard Instruments, Inc. · Apr 1998
PLANCON MICROLAMELLAR KERATOME EVOLUTION
K980924 · Plancon Instruments · Apr 1998
AUTOMATED DISPOSABLE KERATOME (ADK)
K974004 · Lasersight Technologies, Inc. · Jan 1998
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