Cleared Traditional

K855100 - S.L.T. CONTACT LASER SYSTEM

K855100 is an FDA 510(k) clearance for S.L.T. CONTACT LASER SYSTEM, manufactured by Surgical Laser Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K855100 · Surgical Laser Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
65d
Days
Class 2
Risk

K855100 is an FDA 510(k) clearance for the S.L.T. CONTACT LASER SYSTEM. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Surgical Laser Technologies, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 65 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 Surgical Laser Technologies, Inc. devices

FDA 510(k) Submission Details - K855100

510(k) Number K855100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date February 26, 1986
Days to Decision 65 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 130d · This submission: 65d
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 33
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K855100.
OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO
K861173 · Trimedyne, Inc. · Jul 1986
#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL
K861903 · Cooper Lasersonics, Inc. · Jun 1986
HGM, INC. LASERCATH (STERILE)
K860357 · Hgm, Inc. · Apr 1986
S.L.T. CONTACT LASER
K855119 · Surgical Laser Technologies, Inc. · Feb 1986
S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER
K854669 · Surgical Laser Technologies, Inc. · Feb 1986
MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY
K860152 · Endo Lase, Inc. · Feb 1986