FDA.reportPublic FDA data

Feng-Yu Lee

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96805483003247551Feng-Yu Lee1N2026-01-0129122 Rancho Viejo Rd., Suite 212 San Juan Capistrano CA US 92675
30041831483004183148Feng-Yu Lee1N2026-01-0129122 Rancho Viejo Rd., Suite 212 San Juan Capistrano CA US 92675
30080885883008088588Feng-Yu Lee1N2026-01-0129122 Rancho Viejo Rd., Suite 212 San Juan Capistrano CA US 92675
30146745173014674517Feng-Yu Lee1N2026-01-0129122 Rancho Viejo Rd., Suite 212 San Juan Capistrano CA US 92675
30157975593015797559Feng-Yu Lee1N2026-01-0129122 Rancho Viejo Road, Suite 212 San Juan Capistrano CA US 92675
30085345203008534520Feng-Yu Lee1N2020-04-2529122 Rancho Viejo Road, Suite 212 San Juan Capistrano CA US 92675
30143757163014375716Feng-Yu Lee1N2020-04-2529122 Rancho Viejo Road, Suite 212 San Juan Capistrano CA US 92675

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2921401945232871K242575Stereotaxic Guiding Surgical Devices, NaoTrac SHAW2025-05-23
223681481811179K240637RIGHTEST Blood Glucose Monitoring System Max TelNBW2024-11-04
223681923928776K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceQRL2022-09-26
2206231798402632K220907The iNAP One Sleep Therapy SystemOZR2023-06-16
2206231446730406K193460The iNAP One Sleep Therapy SystemOZR2020-05-26
223681692769061K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SBNBW2019-06-02
223681802072936K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max PlusNBW2018-08-17
223681214156514K173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz PlusNBW2018-06-19
2267691418143630K173127skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)LCP2018-09-25
2267691253078441K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerCJE2018-01-25
223681164751093K170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,NBW2017-07-06
223681567556310K161790iGlucose Blood Glucose Monitoring SystemNBW2017-05-02
2206231988348565K152660HYPNOSPADLRK2016-11-09
1107401425594706K151295Biodenta Customized Abutment - TitaniumNHA2015-12-01
1227011543911230K151295Biodenta Customized Abutment - TitaniumNHA2015-12-01
1227011624384794K150296Biodenta Customized Abutment-HybridNHA2015-07-02
1107401838133315K150296Biodenta Customized Abutment-HybridNHA2015-07-02
223681107221925K143387GE333 Blood Glucose Monitoring SystemNBW2015-06-03
223681446551062K141292Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring SystemNBW2015-06-09
223681891250985K140210RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720NBW2014-08-22
1107401620670812K133884BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MMDZE2014-06-13
1227011921550694K133884BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MMDZE2014-06-13
223681449110027K133522RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEMNBW2014-04-17
223682012896492K133003RIGHTEST CONTROL SOLUTIONJJX2013-10-24
2206231439756545K132003WINX SLEEP THERAPY SYSTEMOZR2014-06-13
2206231660044846K130538WINX SLEEP THERAPY SYSTEMOZR2013-05-22
1107401612297997K123512BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MMDZE2013-03-28
1227012064851509K123512BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MMDZE2013-03-28
1107401304054822K123491BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENTNHA2013-05-30
1227011719837357K123491BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENTNHA2013-05-30
1107401110568083K123415BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPEREDDZE2013-03-19
1227011573281989K123415BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPEREDDZE2013-03-19
223681623819171K123008RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORINNBW2013-01-25
1227011075346858K122559BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTSNHA2013-05-03
1107401219691706K122559BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTSNHA2013-05-03
2206231586014965K122130WINX SLEEP THERAPY SYSTEMOZR2012-10-31
223681314874990K120423BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650NBW2012-08-03
223681453366046K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0JQP2012-02-27
2206231200488128K111549ATTUNE SLEEP APNEA SYSTEMOZR2012-03-30
1227011287870723K111003BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVELDZE2011-09-15
1107401657639618K111003BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVELDZE2011-09-15
223681042165321K110737RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700NBW2012-03-29
1107401291255046K093630BIODENTA DENTAL IMPLANT SYSTEMDZE2010-06-03
1227011438372605K093630BIODENTA DENTAL IMPLANT SYSTEMDZE2010-06-03
223681187617010K092052RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550NBW2010-06-18
223681324046502K081451RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100NBW2008-09-18
223681841233101K081450RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110NBW2008-09-11
223681899911702K072054RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310NBW2008-02-28
223681266568000K062567RIGHTEST BLOOD GLUCOSE MONITORING SYSTEMNBW2007-02-16
485091109740790K060342ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701KDXN2006-04-04
223682073513909K053635MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEMNBW2006-02-21
485091954008839K053006ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS IIDXQ2006-02-03
223681096349017K042678RIGHTEST BLOOD GLUCOSE MONITORING SYSTEMNBW2005-01-03
1227011064517734
223681848381933
2921401553564555
2206231902573803
1107401924864433

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW212024-11-04
DZE102014-06-13
NHA82015-12-01
OZR62023-06-16
HAW12025-05-23
QRL12022-09-26
LCP12018-09-25
CJE12018-01-25
LRK12016-11-09
JJX12013-10-24
JQP12012-02-27
DXN12006-04-04
DXQ12006-02-03