Cleared Traditional

K933079 - ELECTROCAUTERY SYSTEM MODEL 1980

K933079 is the FDA 510(k) clearance for ELECTROCAUTERY SYSTEM MODEL 1980 by Pmt Corp.. It is a Class 2 Ophthalmic device (product code HQP) cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K933079 · Pmt Corp. · Ophthalmic device
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Feb 1994
Decision
244d
Days
Class 2
Risk

K933079 is an FDA 510(k) clearance for the ELECTROCAUTERY SYSTEM MODEL 1980. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 244 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - 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 Pmt Corp. devices

Submission Details

510(k) Number K933079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1993
Decision Date February 22, 1994
Days to Decision 244 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
134d slower than avg
Panel avg: 110d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQP Unit, Cautery, Thermal, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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.

Regulatory Peers - HQP Unit, Cautery, Thermal, Battery-powered

Devices cleared under the same product code (HQP) and FDA review panel - the closest regulatory comparables to K933079.
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE
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LOW TEMPERATURE CAUTERY ELONGATED FINE TIP
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OPHTHALMIC CAUTERY
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XOMED THERMAL MYRINGOTOMY SYSTEM
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