Cleared Traditional

MEDICAL LASER ENDOCOAGULATOR 5K

K840854 · Hgm, Inc. · Ophthalmic

Apr 1984

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K840854 is an FDA 510(k) clearance for the MEDICAL LASER ENDOCOAGULATOR 5K, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Hgm, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1984, 38 days after receiving the submission on February 24, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K840854 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 1984
Decision Date	April 02, 1984
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—