Cleared Traditional

K872031 - UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM

K872031 is an FDA 510(k) clearance for UNI-FIBER NON-REPAIRABLE FIBER DELIVERY..., manufactured by Laser Media. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K872031 · Laser Media · Gastroenterology & Urology device
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Aug 1987
Decision
70d
Days
Class 2
Risk

K872031 is an FDA 510(k) clearance for the UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Laser Media (Hauppauge, US). The FDA issued a Cleared decision on August 4, 1987 after a review of 70 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 Laser Media devices

FDA 510(k) Submission Details - K872031

510(k) Number K872031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1987
Decision Date August 04, 1987
Days to Decision 70 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
61d faster than avg
Panel avg: 131d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNK Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K872031.
KTP/532 LASER
K873330 · Laserscope · Nov 1987
SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE
K871865 · Sharplan Lasers, Inc. · Sep 1987
ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.
K872630 · Hgm, Inc. · Aug 1987
SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE
K871348 · Sharplan Lasers, Inc. · Jun 1987
MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.
K871029 · Directed Energy, Inc. · May 1987
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
K871032 · Directed Energy, Inc. · May 1987