Cleared Traditional

K941495 - RETURN PATH DIATHERMY HANDLE (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941495 · Mira, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
109d
Days
Class 2
Risk

K941495 is an FDA 510(k) clearance for the RETURN PATH DIATHERMY HANDLE. Classified as Apparatus, Cautery, Radiofrequency, Ac-powered (product code HQR), Class II - Special Controls.

Submitted by Mira, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 15, 1994 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4100 - 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

Submission Details

510(k) Number K941495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1994
Decision Date July 15, 1994
Days to Decision 109 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 110d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQR Apparatus, Cautery, Radiofrequency, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4100
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.