OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION— 510(k) K902263

Name: FDA 510(k) clearance K902263
Creator: U.S. Food and Drug Administration
Published: 1990-07-23

Substantially Equivalent

Trimedyne, Inc.

FDA 510(k) clearance K902263 for OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION, Substantially Equivalent on 1990-07-23. Applicant: Trimedyne, Inc.. Device class: 1.

Clearance details

Applicant: Trimedyne, Inc.
Product code: Code GGX
Device class: Class 1
Regulation: 21 CFR 864.6160
Advisory panel: Hematology
Date received: 1990-05-21
Decision date: 1990-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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