MODEL 5050 SURGILASER FOR OB-GYN USE— 510(k) K871875

Name: FDA 510(k) clearance K871875
Creator: U.S. Food and Drug Administration
Published: 1988-08-22

Substantially Equivalent

Lasermatic, Inc.

FDA 510(k) clearance K871875 for MODEL 5050 SURGILASER FOR OB-GYN USE, Substantially Equivalent on 1988-08-22. Applicant: Lasermatic, Inc.. Device class: 2.

Clearance details

Applicant: Lasermatic, Inc.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1987-05-14
Decision date: 1988-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHR

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K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE1988-06-01
K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE1988-05-31

More clearances from Lasermatic, Inc.

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K903131 — LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM1991-02-19
K901638 — MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 331990-06-27
K893529 — COMBOLASER MODEL 50501989-06-08
K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE1988-03-25
K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE1988-03-25

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