Cleared Traditional

K992978 - RICROKERATOME BLADE

K992978 is an FDA 510(k) clearance for RICROKERATOME BLADE, manufactured by Surgistar, Inc.. The device is a Class 1 Ophthalmic device with product code HNO cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K992978 · Surgistar, Inc. · Ophthalmic device
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Nov 1999
Decision
74d
Days
Class 1
Risk

K992978 is an FDA 510(k) clearance for the RICROKERATOME BLADE. Classified as Keratome, Ac-powered (product code HNO), Class I - General Controls.

Submitted by Surgistar, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 16, 1999 after a review of 74 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 Surgistar, Inc. devices

FDA 510(k) Submission Details - K992978

510(k) Number K992978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1999
Decision Date November 16, 1999
Days to Decision 74 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
36d faster than avg
Panel avg: 110d · This submission: 74d
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 49
Devices cleared under the same product code (HNO) and FDA review panel - the closest regulatory comparables to K992978.
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015 · Surgin Surgical Instrumentation, Inc. · Mar 2000
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
K993190 · Surgical Instrument Systems (Sis), Ltd. · Feb 2000
ULTRASHAPER KERATOME
K990227 · Lasersight Technologies, Inc. · Jan 2000
MICROKERATOME, MODEL MK-2000
K990900 · Nidek, Inc. · Sep 1999
KERAVISION VACUUM RING SYSTEM
K984540 · Keravision, Inc. · Apr 1999
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K980675 · Summit Technology, Inc. · Dec 1998