Cleared Traditional

SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR

K931356 · Sorenson Laboratories, Inc. · Ophthalmic

Sep 1993

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K931356 is an FDA 510(k) clearance for the SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR, a Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (Class II — Special Controls, product code LQJ), submitted by Sorenson Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 7, 1993, 174 days after receiving the submission on March 17, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K931356 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1993
Decision Date	September 07, 1993
Days to Decision	174 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF