Cleared Traditional

INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM

K890509 · Biophysic Medical, Inc. · Ophthalmic

Mar 1989

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K890509 is an FDA 510(k) clearance for the INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Biophysic Medical, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on March 24, 1989, 51 days after receiving the submission on February 1, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K890509 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 1989
Decision Date	March 24, 1989
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—