Cleared Traditional

K880193 - MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
(FDA 510(k) Clearance)

K880193 · Sharplan Lasers, Inc. · Gastroenterology & Urology

Apr 1988

Decision

86d

Days

Class 2

Risk

K880193 is an FDA 510(k) clearance for the MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE. This device is classified as a Laser For Gastro-urology Use (Class II — Special Controls, product code LNK).

Submitted by Sharplan Lasers, Inc. (Allendale, US). The FDA issued a Cleared decision on April 14, 1988, 86 days after receiving the submission on January 19, 1988.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K880193 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 1988
Decision Date	April 14, 1988
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—