Lutronic Global

FDA Filings

This page includes the latest FDA filings for Lutronic Global. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004483538
FEI Number3004483538
NameKalpana Panigrahi
Owner & OperatorLutronic Global
Contact Address19 Fortune Drive
Billerica MA 01821 US
Official Correspondent
  • Kalpana Panigrahi
  • x-888-5887644-121
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address19 Fortune Drive
Billerica, MA 01821 US
Establishment TypeManufacture Medical Device



Registration Number3013789508
FEI Number3013789508
NameKalpana Panigrahi
Owner & OperatorLutronic Global
Contact Address19 Fortune Drive
Billerica MA 01821 US
Official Correspondent
  • Kalpana Panigrahi
  • x-888-5887644-121
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address19 Fortune Drive
Billerica, MA 01821 US
Establishment TypeManufacture Medical Device



Registration Number3006247712
FEI Number3006247712
NameLutronic Global
Owner & OperatorLutronic Global
Contact Address19 Fortune Drive
Billerica MA 01821 US
Official Correspondent
  • Kalpana Panigrahi
  • x-888-5887644-121
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address19 Fortune Drive
Billerica, MA 01821 US



FDA Filings

Device
Company
DeviceDate
Kalpana Panigrahi [Lutronic Global]
LaseMD Ultra2019-12-19
Kalpana Panigrahi [Lutronic Global]
LaseMD Ultra2019-12-19
Lutronic Global
LaseMD LEO Laser System2019-11-12
Kalpana Panigrahi [Lutronic Global]
Clarity II Laser System2019-08-20
Kalpana Panigrahi [Lutronic Global]
Clarity II Laser System2019-08-20
Kalpana Panigrahi [Lutronic Global]
PICOPLUS Laser System2018-07-30
Kalpana Panigrahi [Lutronic Global]
PICOPLUS Laser System2018-07-30
Kalpana Panigrahi [Lutronic Global]
LASEMD Laser System2017-07-26
Kalpana Panigrahi [Lutronic Global]
LASEMD Laser System2017-07-26
Kalpana Panigrahi [Lutronic Global]
ACTION II Laser System2017-07-26
Kalpana Panigrahi [Lutronic Global]
ACTION II Laser System2017-07-26
Kalpana Panigrahi [Lutronic Global]
ACTION II Laser System2017-07-26
Kalpana Panigrahi [Lutronic Global]
ACTION II Laser System2017-07-26
Kalpana Panigrahi [Lutronic Global]
R:GEN Laser System2017-01-12
Kalpana Panigrahi [Lutronic Global]
R:GEN Laser System2017-01-12
Kalpana Panigrahi [Lutronic Global]
ADVANTAGE Laser System2014-11-25
Kalpana Panigrahi [Lutronic Global]
ADVANTAGE Laser System2014-11-25
Kalpana Panigrahi [Lutronic Global]
CLARITY LPC Laser System2014-01-30
Kalpana Panigrahi [Lutronic Global]
CLARITY LPC Laser System2014-01-30
Kalpana Panigrahi [Lutronic Global]
INFINI Radiofrequency System2013-07-15
Kalpana Panigrahi [Lutronic Global]
INFINI Radiofrequency System2013-07-15
Kalpana Panigrahi [Lutronic Global]
HEALITE II System2013-01-14
Kalpana Panigrahi [Lutronic Global]
HEALITE II System2013-01-14
Kalpana Panigrahi [Lutronic Global]
SPECTRA Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
SPECTRA Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
eCO2 Plus Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
eCO2 Plus Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
SP III Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
SP III Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
DENTA III+ Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
DENTA III+ Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
DENTA III Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
DENTA III Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
eCO2 Plus Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
eCO2 Plus Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
SP III Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
SP III Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
DENTA III+ Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
DENTA III+ Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
DENTA III Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
DENTA III Laser System2013-01-14
Kalpana Panigrahi [Lutronic Global]
SPECTRA DENTA II2009-09-18
Kalpana Panigrahi [Lutronic Global]
SPECTRA DENTA II2009-09-18

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