Cleared Special

K040015 - MODIFICATION TO PRISMALIX SURGICAL LIGHT

K040015 is an FDA 510(k) clearance for MODIFICATION TO PRISMALIX SURGICAL LIGHT, manufactured by Alm S.A.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Special 510(k) pathway after a 16-day FDA review.

K040015 · Alm S.A. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
16d
Days
Class 2
Risk

K040015 is an FDA 510(k) clearance for the MODIFICATION TO PRISMALIX SURGICAL LIGHT. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Alm S.A. (Rochester, US). The FDA issued a Cleared decision on January 21, 2004 after a review of 16 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.

FDA 510(k) Submission Details - K040015

510(k) Number K040015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2004
Decision Date January 21, 2004
Days to Decision 16 days
Submission Type Special
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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
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.

Regulatory Peers - FSY Light, Surgical, Ceiling Mounted

All 73
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K040015.
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K030906 · Alm · Apr 2003
K040015 · MODIFICATION TO PRISMALIX SURGICAL LIGHT
Download PDF FDA Summary Alm S.A.