Cleared Traditional

HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K

K850572 · Hgm, Inc. · Ophthalmic

Apr 1985

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K850572 is an FDA 510(k) clearance for the HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 23, 1985, 69 days after receiving the submission on February 13, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K850572 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 1985
Decision Date	April 23, 1985
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—