Cleared Traditional

K121441 - CAUTERY (FDA 510(k) Clearance)

Also includes:
LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)

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

K121441 · Bovie Medical Corporation · Ophthalmic device
Jul 2012
Decision
66d
Days
Class 2
Risk

K121441 is an FDA 510(k) clearance for the CAUTERY. Classified as Unit, Cautery, Thermal, Battery-powered (product code HQP), Class II - Special Controls.

Submitted by Bovie Medical Corporation (Clearwater, US). The FDA issued a Cleared decision on July 20, 2012 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K121441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2012
Decision Date July 20, 2012
Days to Decision 66 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 156d · This submission: 66d
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.