MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE— 510(k) K880930

Name: FDA 510(k) clearance K880930
Creator: U.S. Food and Drug Administration
Published: 1988-05-31

Substantially Equivalent

Copper Lasersonics, Inc.

FDA 510(k) clearance K880930 for MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE, Substantially Equivalent on 1988-05-31. Applicant: Copper Lasersonics, Inc.. Device class: 2.

Clearance details

Applicant: Copper Lasersonics, Inc.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1988-03-04
Decision date: 1988-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

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K874615 — LASER CANNISTER FILTER1988-06-23
K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE1988-06-01

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