Cleared Traditional

K861173 - OPTILASE YAG MODEL 1000 SURG LASER SYST...

K861173 is an FDA 510(k) clearance for OPTILASE YAG MODEL 1000 SURG LASER SYST..., manufactured by Trimedyne, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K861173 · Trimedyne, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
119d
Days
Class 2
Risk

K861173 is an FDA 510(k) clearance for the OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Trimedyne, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 25, 1986 after a review of 119 days - within the typical 510(k) review window.

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

View all Trimedyne, Inc. devices

FDA 510(k) Submission Details - K861173

510(k) Number K861173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date July 25, 1986
Days to Decision 119 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
11d faster than avg
Panel avg: 130d · This submission: 119d
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 K861173.
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM
K862598 · Laserscope · Nov 1986
CONTACT TIPS
K861955 · Cooper Lasersonics, Inc. · Aug 1986
ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE
K861331 · Trimedyne, Inc. · Aug 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 SYSTEM
K855100 · Surgical Laser Technologies, Inc. · Feb 1986