MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE— 510(k) K871579

Name: FDA 510(k) clearance K871579
Creator: U.S. Food and Drug Administration
Published: 1987-11-16

Substantially Equivalent

Sharplan Lasers, Inc.

FDA 510(k) clearance K871579 for MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE, Substantially Equivalent on 1987-11-16. Applicant: Sharplan Lasers, Inc.. Device class: 2.

Clearance details

Applicant: Sharplan Lasers, Inc.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1987-04-23
Decision date: 1987-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHR

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K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE1988-08-22
K875314 — GL-35 COLPOSCOPIC LASER SYSTEM1988-08-05
K874615 — LASER CANNISTER FILTER1988-06-23
K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE1988-06-01

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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

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