Guardian 1000

Powered Laser Surgical Instrument

Quanta System SpA

The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Guardian 1000.

Pre-market Notification Details

Device IDK151629
510k NumberK151629
Device Name:Guardian 1000
ClassificationPowered Laser Surgical Instrument
Applicant Quanta System SpA Via IV Novembre, 116 Solbiate Olona (va),  IT 21058
ContactFrancesco Dell'antonio
CorrespondentFrancesco Dell'antonio
Quanta System SpA Via IV Novembre, 116 Solbiate Olona (va),  IT 21058
Product CodeGEX  
Subsequent Product CodeILY
Subsequent Product CodePDZ
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-17
Decision Date2015-10-27
Summary:summary

Trademark Results [Guardian 1000]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GUARDIAN 1000
GUARDIAN 1000
78083854 2563910 Dead/Cancelled
AIRCELL, LLC
2001-09-13

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