Cleared Traditional

K973466 - HANAULUX BLUE 75 AND HANAULUX BLUE 120

K973466 is an FDA 510(k) clearance for HANAULUX BLUE 75 AND HANAULUX BLUE 120, manufactured by Heraeus Med GmbH. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K973466 · Heraeus Med GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
70d
Days
Class 2
Risk

K973466 is an FDA 510(k) clearance for the HANAULUX BLUE 75 AND HANAULUX BLUE 120. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Heraeus Med GmbH (Hanau, DE). The FDA issued a Cleared decision on October 24, 1997 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heraeus Med GmbH devices

FDA 510(k) Submission Details - K973466

510(k) Number K973466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1997
Decision Date October 24, 1997
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 29
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K973466.
BRIGHTSTAR
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CHROMOPHARE
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CHROMOPHARE
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K943288 · American Sterilizer Co. · Oct 1994