Cleared Traditional

K843156 - BIOLAS YAG 100 CILAS

K843156 is the FDA 510(k) clearance for BIOLAS YAG 100 CILAS by Advanced Biomedical Instruments. It is a Class 2 Gastroenterology & Urology device (product code LNK) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K843156 · Advanced Biomedical Instruments · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
52d
Days
Class 2
Risk

K843156 is an FDA 510(k) clearance for the BIOLAS YAG 100 CILAS, ERCELAS YAG 100. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Advanced Biomedical Instruments (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4810 - the FDA gastroenterology and urology 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 Advanced Biomedical Instruments devices

Submission Details

510(k) Number K843156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1984
Decision Date October 01, 1984
Days to Decision 52 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 130d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNK Laser For Gastro-urology Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LNK Laser For Gastro-urology Use

All 26
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K843156.
HOTIP HEMOSTATIC PROBE
K843628 · Trimedyne, Inc. · Nov 1985
MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE
K850728 · Cooper Lasersonics, Inc. · Apr 1985
LASER FOR GENITOURINARY APPLIC. 4000
K843240 · Cooper Lasersonics, Inc. · Oct 1984
COOPER LASERSONICS, 8000 ND.YAGLASER
K841869 · Cooper Lasersonics, Inc. · Aug 1984
YAG LASER 8000 - LOWER GI APPLICAT
K840142 · Cooper Lasersonics, Inc. · May 1984
MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000
K833480 · Cooper Lasersonics, Inc. · Dec 1983