MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE— 510(k) K880256

Name: FDA 510(k) clearance K880256
Creator: U.S. Food and Drug Administration
Published: 1988-04-14

Substantially Equivalent

Sharplan Lasers, Inc.

FDA 510(k) clearance K880256 for MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE, Substantially Equivalent on 1988-04-14. Applicant: Sharplan Lasers, Inc.. Device class: 2.

Clearance details

Applicant: Sharplan Lasers, Inc.
Product code: Code LNK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1988-01-20
Decision date: 1988-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNK

view all

K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM1993-05-21
K901723 — MDL-2000 LASERTRIPTER1990-07-13
K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.1988-07-12
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

More clearances from Sharplan Lasers, Inc.

view all

K973354 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)1997-12-04
K972099 — SHARPLAN EPITOUCH RUBY LASER SYSTEM1997-08-27
K971874 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)1997-08-18
K971648 — SHARPLAN ERBIUM: YAG LASER (4020)1997-07-23
K971743 — SHARPLAN CO2 SURGICAL LASER SYSTEM1997-07-18

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