DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30

Powered Laser Surgical Instrument

QUANTA SYSTEM, S.P.A.

The following data is part of a premarket notification filed by Quanta System, S.p.a. with the FDA for Diode Medical Laser Family, Models 4, 6, 30.

Pre-market Notification Details

Device IDK072034
510k NumberK072034
Device Name:DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30
ClassificationPowered Laser Surgical Instrument
Applicant QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona(va),  IT 21058
ContactIsabella Carrer
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-07-25
Decision Date2007-09-20
Summary:summary

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