Cleared Abbreviated

K123587 - HEINE MINI 3000 LED OPHTHALMOSCOPE
(FDA 510(k) Clearance)

K123587 · Heine Optotechnik GmbH & Co. KG · Ophthalmic

Mar 2013

Decision

121d

Days

Class 2

Risk

K123587 is an FDA 510(k) clearance for the HEINE MINI 3000 LED OPHTHALMOSCOPE. This device is classified as a Ophthalmoscope, Battery-powered (Class II — Special Controls, product code HLJ).

Submitted by Heine Optotechnik GmbH & Co. KG (Herrsching, DE). The FDA issued a Cleared decision on March 22, 2013, 121 days after receiving the submission on November 21, 2012.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K123587 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2012
Decision Date	March 22, 2013
Days to Decision	121 days
Submission Type	Abbreviated
Review Panel	Ophthalmic (OP)
Summary	Summary PDF