Cleared Traditional

PANORET, MODEL 1000A

K001111 · Cmt Medical Technologies, Ltd. · Ophthalmic

Jul 2000

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K001111 is an FDA 510(k) clearance for the PANORET, MODEL 1000A, a Retinoscope, Ac-powered (Class II — Special Controls, product code HKL), submitted by Cmt Medical Technologies, Ltd. (Haifa, IL). The FDA issued a Cleared decision on July 7, 2000, 92 days after receiving the submission on April 6, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1780.

Submission Details

510(k) Number	K001111 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2000
Decision Date	July 07, 2000
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF