Cleared Traditional

LASERMATIC SURGILASER MODEL 5050

K870587 · Lasermatic OY · Ear, Nose, Throat

Aug 1988

Decision

547d

Days

Class 2

Risk

About This 510(k) Submission

K870587 is an FDA 510(k) clearance for the LASERMATIC SURGILASER MODEL 5050, a Laser, Ent Microsurgical Carbon-dioxide (Class II — Special Controls, product code EWG), submitted by Lasermatic OY (Finland, FI). The FDA issued a Cleared decision on August 10, 1988, 547 days after receiving the submission on February 10, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4500.

Submission Details

510(k) Number	K870587 FDA.gov
FDA Decision	Cleared SN
Date Received	February 10, 1987
Decision Date	August 10, 1988
Days to Decision	547 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—