Cleared Traditional

REFRACTEC MCS-100

K980522 · Refractec, Inc. · Ophthalmic

Jul 1998

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K980522 is an FDA 510(k) clearance for the REFRACTEC MCS-100, a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II — Special Controls, product code HQR), submitted by Refractec, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on July 22, 1998, 162 days after receiving the submission on February 10, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number	K980522 FDA.gov
FDA Decision	Cleared SESU
Date Received	February 10, 1998
Decision Date	July 22, 1998
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement