Cleared Traditional

K013151 - ASMOTOM AUTOMATED TREPHINE SYSTEM
(FDA 510(k) Clearance)

K013151 · Bkg Opthalmics USA, Inc. · Ophthalmic device

Dec 2001

Decision

85d

Days

Class 1

Risk

K013151 is an FDA 510(k) clearance for the ASMOTOM AUTOMATED TREPHINE SYSTEM. This device is classified as a Engine, Trephine, Accessories, Ac-powered (Class I - General Controls, product code HRG).

Submitted by Bkg Opthalmics USA, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on December 14, 2001, 85 days after receiving the submission on September 20, 2001.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4070.

Submission Details

510(k) Number	K013151 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 20, 2001
Decision Date	December 14, 2001
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF