MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA— 510(k) K863361

Name: FDA 510(k) clearance K863361
Creator: U.S. Food and Drug Administration
Published: 1986-11-24

Substantially Equivalent

Cooper Lasersonics, Inc.

FDA 510(k) clearance K863361 for MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA, Substantially Equivalent on 1986-11-24. 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: 1986-09-02
Decision date: 1986-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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