Cleared Traditional

K971750 - WELCH ALLYN PHACO ILLUMINATOR (FDA 510(k) Clearance)

K971750 · Welch Allyn, Inc. · Ophthalmic device

Jun 1997

Decision

49d

Days

Class 2

Risk

K971750 is an FDA 510(k) clearance for the WELCH ALLYN PHACO ILLUMINATOR. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on June 30, 1997, 49 days after receiving the submission on May 12, 1997.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K971750 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 12, 1997
Decision Date	June 30, 1997
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF