BIOLASE MG LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20277552027755BIOLASE MG LLC1N2026-01-0127042 Towne Centre Drive Suite 270 Foothill Ranch CA US 92610
30171251613017125161BIOLASE MG LLC1N2026-01-014225 Prado Road Suite 102 Corona CA US 92880

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3356621633898231K213428EdgeProNVK2021-12-22
3357241633898231K213428EdgeProNVK2021-12-22
3357241776142385K210183Waterlase iPLusGEX2022-04-21
3356621776142385K210183Waterlase iPLusGEX2022-04-21
3356621343822897K192430Epic 980GEX2019-12-04
3357241343822897K192430Epic 980GEX2019-12-04
3357242067314539K172771Epic Pro 940GEX2017-11-29
3356622067314539K172771Epic Pro 940GEX2017-11-29
3356621214287592K163128Epic ProGEX2017-01-11
3357241214287592K163128Epic ProGEX2017-01-11
3356621568277975K161669Waterlase ExpressGEX2016-07-28
3357241568277975K161669Waterlase ExpressGEX2016-07-28
3356621271135530K130465EPIC 10SGEX2013-04-11
3357241271135530K130465EPIC 10SGEX2013-04-11
3356621343740127K121286EPIC 10GEX2012-09-28
3357241343740127K121286EPIC 10GEX2012-09-28
3357241075494269K101658WATERLASE MD TURBO PLUS MODEL 7200XXXGEX2010-08-11
3356621075494269K101658WATERLASE MD TURBO PLUS MODEL 7200XXXGEX2010-08-11
3357241437286504K093852EZLASE 3 LASER SYSTEMGEX2010-03-12
3356621437286504K093852EZLASE 3 LASER SYSTEMGEX2010-03-12
3356621752381985K090181WATERLASE MDGEX2009-02-11
3357241752381985K090181WATERLASE MDGEX2009-02-11
3356621238772526K031140WATERLASEGEX2004-07-07
3357241238772526K031140WATERLASEGEX2004-07-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX222022-04-21
NVK22021-12-22