Cleared Traditional

CERMAX300 LIGHTSOURCE

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

About This 510(k) Submission

K981469 is an FDA 510(k) clearance for the CERMAX300 LIGHTSOURCE, a Light, Surgical, Floor Standing (Class II — Special Controls, product code FSS), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on July 9, 1998, 77 days after receiving the submission on April 23, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K981469 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FSS — Light, Surgical, Floor Standing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

Similar Devices — FSS Light, Surgical, Floor Standing

All 19
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)
K091246 · Trumpf Medizin Systeme GmbH + Co. KG · Sep 2009
NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8
K003489 · Medical Illumination International, Inc. · Feb 2001
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