Cleared Traditional

K893816 - HEMOLASER HEMOSCOPE

K893816 is an FDA 510(k) clearance for HEMOLASER HEMOSCOPE, manufactured by Hemolaser Corp.. The device is a Class 2 Cardiovascular device with product code LYK cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K893816 · Hemolaser Corp. · Cardiovascular device
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Feb 1990
Decision
254d
Days
Class 2
Risk

K893816 is an FDA 510(k) clearance for the HEMOLASER HEMOSCOPE. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Hemolaser Corp. (Irvine, US). The FDA issued a Cleared decision on February 1, 1990 after a review of 254 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 876.1500 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hemolaser Corp. devices

FDA 510(k) Submission Details - K893816

510(k) Number K893816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1989
Decision Date February 01, 1990
Days to Decision 254 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 125d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYK Device Classification - Class 2, Special Controls

Product Code LYK Angioscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LYK Angioscope

All 24
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K893816.
4.5F IMAGECATH ANGIOSCOPE
K905083 · Baxter Healthcare Corp · Jun 1991
ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY
K895538 · Trimedyne, Inc. · Apr 1990
CVIS INSIGHT IMAGING CATHETER
K897153 · Cardiovascular Imaging Systems, Inc. · Mar 1990
ACS ANGIOSCOPE GUIDE WIRE
K883000 · Advanced Cardiovascular Systems, Inc. · Sep 1988
ACS CORONARY ANGIOSCOPIC CATHETER
K875108 · Advanced Cardiovascular Systems, Inc. · Sep 1988
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
K860858 · Olympus Corp. · Nov 1986