Cleared Traditional

K011195 - PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
(FDA 510(k) Clearance)

K011195 · Surgin Surgical Instrumentation, Inc. · Ophthalmic

Nov 2001

Decision

201d

Days

Class 1

Risk

K011195 is an FDA 510(k) clearance for the PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB. This device is classified as a Keratome, Ac-powered (Class I — General Controls, product code HNO).

Submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on November 6, 2001, 201 days after receiving the submission on April 19, 2001.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number	K011195 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2001
Decision Date	November 06, 2001
Days to Decision	201 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement