Cleared Traditional

SI ASCOPE (K011273) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011273 · Astron Clinica Limited · General & Plastic Surgery device
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Feb 2002
Decision
300d
Days
Class 2
Risk

K011273 is an FDA 510(k) clearance for the SI ASCOPE. 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 February 20, 2002 after a review of 300 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. 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 Astron Clinica Limited devices

Submission Details

510(k) Number K011273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2001
Decision Date February 20, 2002
Days to Decision 300 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 115d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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
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