FDA.report

Loupe

Definition
A convex lens with an built-in, electrical light source used for magnifying vision and concentrating the light upon an object or objects being viewed. It can be used for a variety of purposes, e.g., the examination of an object for laboratory work, diagnosis, minor surgery, dermatology, or by persons with a strong eyesight impairment. The loupe is typically mounted on the end of an adjustable arm (e.g., a flexible tube or an articulating arm) which is attached to a stable base or clamped to a surface worktop.
GUDID devices
89
Last updated
2026-01-15 17:33:26

Related Product Codes

CodeDeviceSpecialtyClassDevices
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery158
HPPHeadlamp, Operating, Battery-OperatedOphthalmic129
ERAOtoscopeEar, Nose, Throat12
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00723896025321TTL Easy Size 2.5X Loupes RedPRACTICON, INC.7131117 RED2026-01-07
00723896025338TTL Easy Size 3.0X Loupes RedPRACTICON, INC.7131118 RED2026-01-07
00723896025505TTL Easy Size 2.5X Loupes SilverPRACTICON, INC.7131117 SIL2026-01-07
00723896025512TTL Easy Size 3.0X Loupes SilverPRACTICON, INC.7131118 SIL2026-01-07
00723896030097TTL Easy Size 2.5X Loupes BlackPRACTICON, INC.7131117 BLA2026-01-07
00723896030103TTL Easy Size 3.0X Loupes BlackPRACTICON, INC.7131118 BLA2026-01-07
04048551116715n.a.Karl Storz GmbH & Co. KG290312018-08-21
04048551052402n.a.Karl Storz GmbH & Co. KG1198002019-02-23
04048551052426n.a.Karl Storz GmbH & Co. KG1199002019-02-23
M63398168010JEDMEDJEDMED INSTRUMENT COMPANY98-1680-12023-04-28
M63398168020JEDMEDJEDMED INSTRUMENT COMPANY98-1680-22023-04-28
M63398168030JEDMEDJEDMED INSTRUMENT COMPANY98-1680-32023-04-28
M63398168050JEDMEDJEDMED INSTRUMENT COMPANY98-1680-52023-04-28
M6339817550JEDMEDJEDMED INSTRUMENT COMPANY98-17552023-04-28
M6339817600JEDMEDJEDMED INSTRUMENT COMPANY98-17602023-04-28
M6339817610JEDMEDJEDMED INSTRUMENT COMPANY98-17612023-04-28
M6339818000JEDMEDJEDMED INSTRUMENT COMPANY98-18002023-04-28
M633981800T0JEDMEDJEDMED INSTRUMENT COMPANY98-1800-T2023-04-28
M6339818050JEDMEDJEDMED INSTRUMENT COMPANY98-18052023-04-28
M633981805T0JEDMEDJEDMED INSTRUMENT COMPANY98-1805-T2023-04-28
M6339818150JEDMEDJEDMED INSTRUMENT COMPANY98-18152023-04-28
M633981815T0JEDMEDJEDMED INSTRUMENT COMPANY98-1815-T2023-04-28
M6339818200JEDMEDJEDMED INSTRUMENT COMPANY98-18202023-04-28
M633981820T0JEDMEDJEDMED INSTRUMENT COMPANY98-1820-T2023-04-28
M6339818220JEDMEDJEDMED INSTRUMENT COMPANY98-18222023-04-28
M633981822T0JEDMEDJEDMED INSTRUMENT COMPANY98-1822-T2023-04-28
M6339818240JEDMEDJEDMED INSTRUMENT COMPANY98-18242023-04-28
M633981824T0JEDMEDJEDMED INSTRUMENT COMPANY98-1824-T2023-04-28
M6339818280JEDMEDJEDMED INSTRUMENT COMPANY98-18282023-04-28
M633981828T0JEDMEDJEDMED INSTRUMENT COMPANY98-1828-T2023-04-28
M6339818300JEDMEDJEDMED INSTRUMENT COMPANY98-18302023-04-28
M633981830T0JEDMEDJEDMED INSTRUMENT COMPANY98-1830-T2023-04-28
M6339818350JEDMEDJEDMED INSTRUMENT COMPANY98-18352023-04-28
M6339818360JEDMEDJEDMED INSTRUMENT COMPANY98-18362023-04-28
M6339818370JEDMEDJEDMED INSTRUMENT COMPANY98-18372023-04-28
M6339818380JEDMEDJEDMED INSTRUMENT COMPANY98-18382023-04-28
M6339818400JEDMEDJEDMED INSTRUMENT COMPANY98-18402023-04-28
00860179001099iZoom LoupesDentlight Inc.85000512021-08-09
00192896093799SONTEC ELITE LOUPE LED 5500 SETSONTEC INSTRUMENTS, INC.100-55002019-03-07
00192896071223PROTECTIVE LENSESSONTEC INSTRUMENTS, INC.C-000.32.0272018-09-17
00192896071230RETAINING STRAPSONTEC INSTRUMENTS, INC.C-000.32.3052018-09-17
00192896071247S-FRAME REPLACEMENT PART SETSONTEC INSTRUMENTS, INC.C-000.32.3082018-09-17
00192896071254SIGMA 250 CLIP IN CORRECTION FRAMESONTEC INSTRUMENTS, INC.C-000.32.3092018-09-17
00192896071261HIGH RESOLUTION BINOCULAR LOUPESONTEC INSTRUMENTS, INC.C-000.32.3232018-09-12
00192896071278HIGH RESOLUTION BINOCULAR LOUPESONTEC INSTRUMENTS, INC.C-000.32.3272018-09-12
00192896071285HIGH RESOLUTION PRISMATIC RIDGED MOUNT SETSONTEC INSTRUMENTS, INC.C-000.32.4252018-09-12
00192896071292HIGH RESOLUTION PRISMATIC I-VIEW SETSONTEC INSTRUMENTS, INC.C-000.32.4312018-09-12
00192896071308HIGH RESOLUTION OPTICSSONTEC INSTRUMENTS, INC.C-000.32.5042018-09-12
00192896071315LIGHT WEIGHT HEAD BANDSONTEC INSTRUMENTS, INC.C-000.32.5162018-09-17
00192896071322STERILE SWIVEL LEVERSSONTEC INSTRUMENTS, INC.C-000.32.5242018-09-17
00192896071339UNIVERSAL CLIPSONTEC INSTRUMENTS, INC.C-000.32.5252018-09-17
00192896071346POLAR FILTERSONTEC INSTRUMENTS, INC.C-000.32.5352018-09-17
00192896071353LENS COVERSSONTEC INSTRUMENTS, INC.C-000.32.5372018-09-17
00192896071360STERILIZABLE LEVERSSONTEC INSTRUMENTS, INC.C-000.32.5512018-09-17
00192896071377CARRYING CASESONTEC INSTRUMENTS, INC.C-000.32.5522018-09-17
00192896071384HIGH RESOLUTION BINOCULAR LOUPES SETSONTEC INSTRUMENTS, INC.C-000.32.3562018-09-12
00192896071391HIGH RESOLUTION BINOCULAR LOUPES SETSONTEC INSTRUMENTS, INC.C-000.32.5672018-09-12
00192896071407PARTIAL HIGH RESOLUTION PRISMATIC OPTICSONTEC INSTRUMENTS, INC.C-000.32.7032018-09-12
00192896071414PARTIAL HIGH RESOLUTION PRISMATIC OPTICSONTEC INSTRUMENTS, INC.C-000.32.7052018-09-12
00192896071421HIGH RESOLUTION PRISMATIC LOUPE OPTICSSONTEC INSTRUMENTS, INC.C-000.32.7062018-09-12
00192896071438HIGH RESOLUTION PRISMATIC BINOCULAR LOUPES SETSONTEC INSTRUMENTS, INC.C-000.32.8402018-09-12
00192896071445HIGH RESOLUTION PRISMATIC BINOCULAR LOUPES SETSONTEC INSTRUMENTS, INC.C-000.32.8412018-09-12
00192896071452HIGH RESOLUTION PRISMATIC BINOCULAR LOUPES SETSONTEC INSTRUMENTS, INC.C-000.32.8422018-09-12
00192896071469HIGH RESOLUTION BINOCULAR LOUPES SETSONTEC INSTRUMENTS, INC.C-000.32.8652018-09-12
00192896071476HIGH RESOLUTION BINOCULAR LOUPES SETSONTEC INSTRUMENTS, INC.C-000.32.8662018-09-12
00192896071483HIGH RESOLUTION BINOCULAR LOUPES SETSONTEC INSTRUMENTS, INC.C-000.32.8672018-09-12
00192896071506EN50 INSTRUMENT SUPPORTSONTEC INSTRUMENTS, INC.C-000.33.5122018-09-17
00192896071537LED LOUPE LIGHTSONTEC INSTRUMENTS, INC.C-008.32.2362018-09-18
00192896071544LED LOUPE LIGHTSONTEC INSTRUMENTS, INC.C-008.32.2382018-09-18
00192896071551LED LOUPE LIGHTSONTEC INSTRUMENTS, INC.C-008.32.2462018-09-17
00192896071568HIGH RESOLUTION BINOCULAR LOUPESONTEC INSTRUMENTS, INC.C-008.32.3552018-09-12
00192896071575MPACK LL LED LOUPE LIGHT SETSONTEC INSTRUMENTS, INC.C-008.32.4412018-09-12
00192896071582HIGH RESOULTION LOUPELIGHT SETSONTEC INSTRUMENTS, INC.C-008.32.4502018-09-12
00192896071599HIGH RESOULTION LOUPELIGHT SETSONTEC INSTRUMENTS, INC.C-008.32.4512018-09-12
00192896071681HIGH RESOLUTION LED LOUPESONTEC INSTRUMENTS, INC.J-008.31.3462018-09-12
00192896071742LITHIUM-POLYMER REPLACEMENT BATTERYSONTEC INSTRUMENTS, INC.X-007.99.6802018-09-17
00192896071759OMEGA 500 LED MODULESONTEC INSTRUMENTS, INC.X-008.87.2002018-09-17
00192896071841I-VIEW LOUPE CARRIERSONTEC INSTRUMENTS, INC.Z-763.01.0002018-09-17
00192896071858NOSE PAD SETSONTEC INSTRUMENTS, INC.Z-720.10.0002018-09-17
00192896071865I-VIEWSONTEC INSTRUMENTS, INC.Z-765.22.0002018-09-12