Cleared Traditional

K854027 - LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM

K854027 is the FDA 510(k) clearance for LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM by Laserscope. It is a Class 2 Gastroenterology & Urology device (product code LNK) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K854027 · Laserscope · Gastroenterology & Urology device
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Dec 1985
Decision
62d
Days
Class 2
Risk

K854027 is an FDA 510(k) clearance for the LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Laserscope (Santa Clara, US). The FDA issued a Cleared decision on December 2, 1985 after a review of 62 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 Laserscope devices

Submission Details

510(k) Number K854027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1985
Decision Date December 02, 1985
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
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 25
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K854027.
S.L.T. CONTACT LASER SYSTEM
K855100 · Surgical Laser Technologies, Inc. · Feb 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
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