Cleared Traditional

K870505 - OPTILASE YAG MODEL 1000 SURG LASER SYS/...

K870505 is an FDA 510(k) clearance for OPTILASE YAG MODEL 1000 SURG LASER SYS/..., manufactured by Trimedyne, Inc.. The device is a Class 2 Anesthesiology device with product code LLO cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K870505 · Trimedyne, Inc. · Anesthesiology device
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Aug 1987
Decision
184d
Days
Class 2
Risk

K870505 is an FDA 510(k) clearance for the OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL. Classified as Laser, Neodymium:yag, Pulmonary Surgery (product code LLO), Class II - Special Controls.

Submitted by Trimedyne, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 7, 1987 after a review of 184 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4500 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Trimedyne, Inc. devices

FDA 510(k) Submission Details - K870505

510(k) Number K870505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1987
Decision Date August 07, 1987
Days to Decision 184 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 140d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLO Device Classification - Class 2, Special Controls

Product Code LLO Laser, Neodymium:yag, Pulmonary Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4500
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - LLO Laser, Neodymium:yag, Pulmonary Surgery

All 8
Devices cleared under the same product code (LLO) and FDA review panel - the closest regulatory comparables to K870505.
SLT CLMD CONTACT LASER
K884815 · Surgical Laser Technologies, Inc. · Dec 1988
MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
K880170 · Cooper Lasersonics, Inc. · Mar 1988
6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION
K862698 · Cooper Lasersonics, Inc. · Aug 1986
LASER BRONCHOSCOPE SYSTEM
K861921 · Pilling Co. · Jun 1986
CO2 LASER BRONCHOSCOPE SYSTEM
K861583 · Richard Wolf Medical Instruments Corp. · May 1986
S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA
K855095 · Surgical Laser Technologies, Inc. · Feb 1986