Cleared Special

K130513 - VOLISTA 400 (FDA 510(k) Clearance)

Also includes:
VOLISTA 600

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130513 · Maquet S.A.S. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
70d
Days
Class 2
Risk

K130513 is an FDA 510(k) clearance for the VOLISTA 400. Classified as Lamp, Surgical (product code FTD), Class II - Special Controls.

Submitted by Maquet S.A.S. (Wayne, US). The FDA issued a Cleared decision on May 8, 2013 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Maquet S.A.S. devices

Submission Details

510(k) Number K130513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2013
Decision Date May 08, 2013
Days to Decision 70 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FTD Lamp, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.