Cleared Traditional

K974004 - AUTOMATED DISPOSABLE KERATOME (ADK)

K974004 is an FDA 510(k) clearance for AUTOMATED DISPOSABLE KERATOME (ADK), manufactured by Lasersight Technologies, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K974004 · Lasersight Technologies, Inc. · Ophthalmic device
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Jan 1998
Decision
79d
Days
Class 1
Risk

K974004 is an FDA 510(k) clearance for the AUTOMATED DISPOSABLE KERATOME (ADK). Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Lasersight Technologies, Inc. (Orlando, US). The FDA issued a Cleared decision on January 8, 1998 after a review of 79 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 Lasersight Technologies, Inc. devices

FDA 510(k) Submission Details - K974004

510(k) Number K974004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1997
Decision Date January 08, 1998
Days to Decision 79 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
31d faster than avg
Panel avg: 110d · This submission: 79d
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 42
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K974004.
SCMD-1000
K980985 · Howard Instruments, Inc. · May 1998
MICROKERATOME OR THE MATE
K974598 · Howard Instruments, Inc. · Apr 1998
PLANCON MICROLAMELLAR KERATOME EVOLUTION
K980924 · Plancon Instruments · Apr 1998
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