MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE— 510(k) K850728

Name: FDA 510(k) clearance K850728
Creator: U.S. Food and Drug Administration
Published: 1985-04-08

Substantially Equivalent

Cooper Lasersonics, Inc.

FDA 510(k) clearance K850728 for MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE, Substantially Equivalent on 1985-04-08. Applicant: Cooper Lasersonics, Inc.. Device class: 2.

Clearance details

Applicant: Cooper Lasersonics, Inc.
Product code: Code LNK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1985-02-22
Decision date: 1985-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.1988-07-12
K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE1988-04-14

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K880429 — ILLUMINA 55 CO2 LASER SYSTEM1988-04-18
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