Cleared Traditional

OPHTHALMIC TRICHIASIS PROBE

K923629 · Mira, Inc. · Ophthalmic
Oct 1992
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K923629 is an FDA 510(k) clearance for the OPHTHALMIC TRICHIASIS PROBE, a Unit, Cryophthalmic (Class II — Special Controls, product code HPS), submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on October 19, 1992, 90 days after receiving the submission on July 21, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number K923629 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1992
Decision Date October 19, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HPS — Unit, Cryophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4170