ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION— 510(k) K862456

Name: FDA 510(k) clearance K862456
Creator: U.S. Food and Drug Administration
Published: 1986-08-12

Substantially Equivalent

Cooper Lasersonics, Inc.

FDA 510(k) clearance K862456 for ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION, Substantially Equivalent on 1986-08-12. Applicant: Cooper Lasersonics, Inc.. Device class: 2.

Clearance details

Applicant: Cooper Lasersonics, Inc.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1986-06-27
Decision date: 1986-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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