Cleared Traditional

HGM ILLUMINATING IMAGING ENDOCULAR PROBE

K931784 · Hgm, Inc. · Ophthalmic

Mar 1994

Decision

326d

Days

Class 2

Risk

About This 510(k) Submission

K931784 is an FDA 510(k) clearance for the HGM ILLUMINATING IMAGING ENDOCULAR PROBE, 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 March 1, 1994, 326 days after receiving the submission on April 9, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K931784 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 1993
Decision Date	March 01, 1994
Days to Decision	326 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement