LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL— 510(k) K855146

Name: FDA 510(k) clearance K855146
Creator: U.S. Food and Drug Administration
Published: 1986-04-11

Substantially Equivalent

Laserscope

FDA 510(k) clearance K855146 for LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL, Substantially Equivalent on 1986-04-11. Applicant: Laserscope. Device class: 2.

Clearance details

Applicant: Laserscope
Product code: Code LMS
Device class: Class 2
Regulation: 21 CFR 874.4490
Advisory panel: Ear, Nose, Throat
Date received: 1985-12-24
Decision date: 1986-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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