Cleared Traditional

K923629 - OPHTHALMIC TRICHIASIS PROBE

K923629 is an FDA 510(k) clearance for OPHTHALMIC TRICHIASIS PROBE, manufactured by Mira, Inc.. The device is a Class 2 Ophthalmic device with product code HPS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K923629 is an FDA 510(k) clearance for the OPHTHALMIC TRICHIASIS PROBE. Classified as Unit, Cryophthalmic (product code HPS), Class II - Special Controls.

Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on October 19, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4170 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Mira, Inc. devices

FDA 510(k) Submission Details - K923629

510(k) Number K923629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HPS Device Classification - Class 2, Special Controls

Product Code HPS Unit, Cryophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.