PITANGA

Powered Laser Surgical Instrument

SYNERON MEDICAL LTD.

The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Pitanga.

Pre-market Notification Details

Device IDK031489
510k NumberK031489
Device Name:PITANGA
ClassificationPowered Laser Surgical Instrument
Applicant SYNERON MEDICAL LTD. POB 550 Yokneam Elite,  IL 20692
ContactAmir Waldman
CorrespondentAmir Waldman
SYNERON MEDICAL LTD. POB 550 Yokneam Elite,  IL 20692
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-12
Decision Date2003-08-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109951959 K031489 000
07290109951942 K031489 000
07290109951713 K031489 000
07290109951515 K031489 000
07290109951386 K031489 000
07290109950228 K031489 000
07290109950150 K031489 000
07290109950143 K031489 000

Trademark Results [PITANGA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PITANGA
PITANGA
78766112 3168210 Dead/Cancelled
Syneron Canada Corporation
2005-12-03

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