Cleared Traditional

K130165 - PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0

K130165 is an FDA 510(k) clearance for PICTZAR DIGITAL PLANIMETRY SOFTWARE APP..., manufactured by Advanced Planimetric Services, LLC. The device is a Class 1 General & Plastic Surgery device with product code FXN cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K130165 · Advanced Planimetric Services, LLC · General & Plastic Surgery device
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Aug 2013
Decision
219d
Days
Class 1
Risk

K130165 is an FDA 510(k) clearance for the PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0. Classified as Tape, Camera, Surgical (product code FXN), Class I - General Controls.

Submitted by Advanced Planimetric Services, LLC (Elmwood Park, US). The FDA issued a Cleared decision on August 30, 2013 after a review of 219 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Planimetric Services, LLC devices

FDA 510(k) Submission Details - K130165

510(k) Number K130165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2013
Decision Date August 30, 2013
Days to Decision 219 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

FXN Device Classification - Class 1, General Controls

Product Code FXN Tape, Camera, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.