OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL— 510(k) K870505

Name: FDA 510(k) clearance K870505
Creator: U.S. Food and Drug Administration
Published: 1987-08-07

Substantially Equivalent

Trimedyne, Inc.

FDA 510(k) clearance K870505 for OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL, Substantially Equivalent on 1987-08-07. Applicant: Trimedyne, Inc.. Device class: 2.

Clearance details

Applicant: Trimedyne, Inc.
Product code: Code LLO
Device class: Class 2
Regulation: 21 CFR 874.4500
Advisory panel: Ear, Nose, Throat
Date received: 1987-02-04
Decision date: 1987-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS1988-03-24
K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS1988-03-04

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Data sourced from openFDA. This site is unofficial and independent of the FDA.