Cleared Traditional

K062736 - SIASCOPE V

K062736 is an FDA 510(k) clearance for SIASCOPE V, manufactured by Astron Clinica Limited. The device is a Class 2 General & Plastic Surgery device with product code PSN cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K062736 · Astron Clinica Limited · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
366d
Days
Class 2
Risk

K062736 is an FDA 510(k) clearance for the SIASCOPE V. Classified as Light Based Imaging (product code PSN), Class II - Special Controls.

Submitted by Astron Clinica Limited (Crofton, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K062736

510(k) Number K062736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2006
Decision Date September 14, 2007
Days to Decision 366 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
251d slower than avg
Panel avg: 115d · This submission: 366d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PSN Device Classification - Class 2, Special Controls

Product Code PSN Light Based Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
Definition Emission And Collection Of Light To Create An Image For Medical Purposes
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.

Regulatory Peers - PSN Light Based Imaging

All 9
Devices cleared under the same product code (PSN) and FDA review panel - the closest regulatory comparables to K062736.
Demetra BDEM-01 Dermatoscope
K192829 · Barco N.V. · Dec 2019
VivaScope System
K180162 · Caliber Imaging & Diagnostics, Inc. · May 2018
VIVASCOPE SYSTEM, MODEL 1500, 3000
K080788 · Lucid, Inc. · Sep 2008
MICRODERM, MODEL/VERSION 3.5
K040171 · Visiomed AG · Jun 2004
SIASCOPE II
K023729 · Astron Clinica Limited · Feb 2003
SI ASCOPE
K011273 · Astron Clinica Limited · Feb 2002
K062736 · SIASCOPE V
Download PDF FDA Summary Astron Clinica Limited