Cleared Traditional

K981469 - CERMAX300 LIGHTSOURCE

K981469 is an FDA 510(k) clearance for CERMAX300 LIGHTSOURCE, manufactured by Cuda Products Co.. The device is a Class 2 General & Plastic Surgery device with product code FSS cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K981469 · Cuda Products Co. · General & Plastic Surgery device
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Jul 1998
Decision
77d
Days
Class 2
Risk

K981469 is an FDA 510(k) clearance for the CERMAX300 LIGHTSOURCE. Classified as Light, Surgical, Floor Standing (product code FSS), Class II - Special Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on July 9, 1998 after a review of 77 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 Cuda Products Co. devices

FDA 510(k) Submission Details - K981469

510(k) Number K981469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1998
Decision Date July 09, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSS Device Classification - Class 2, Special Controls

Product Code FSS Light, Surgical, Floor Standing
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 - FSS Light, Surgical, Floor Standing

All 9
Devices cleared under the same product code (FSS) and FDA review panel - the closest regulatory comparables to K981469.
AESCULAP XENON LIGHT SOURCE
K984124 · Aesculap, Inc. · Feb 1999
CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE
K981962 · Cuda Products Co. · Aug 1998
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
K981821 · Angiolaz, Inc. · Jul 1998
XENON 300MX
K980044 · Perkinelmer Optoelectronics · Apr 1998
HANAULUX BLUE 80 HOSPITAL
K970886 · Heraeus Med GmbH · Apr 1997
Q-5000
K961971 · Stryker Endoscopy · Jun 1996