FDA.reportPublic FDA data

Dermatoscope, optical

Definition
An electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structures of the epidermis and epidermal-dermal junction during dermatoscopy (also known as dermascopy). Oil may be applied to the skin to enhance skin transparency. This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).
GUDID devices
339
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04053755124022CONTACT PLATE MINI3000Heine Optotechnik GmbH & Co. KGSTANDARD WITHOUT SCALE2022-12-15
04053755124039CONTACT PLATE MINI3000Heine Optotechnik GmbH & Co. KGSTANDARD WITH SCALE2022-12-15
04053755124848MINI3000Heine Optotechnik GmbH & Co. KG2,5 V WITHOUT SCALE2022-12-12
04053755124909MINI3000Heine Optotechnik GmbH & Co. KG2,5 V WITH SCALE2022-12-12
04053755135387CONTACT PLATE MINI3000Heine Optotechnik GmbH & Co. KGSMALL2022-12-15
04053755135486CONTACT PLATE DELTA 20THeine Optotechnik GmbH & Co. KGSMALL2022-12-15
04053755158782MINI3000 LEDHeine Optotechnik GmbH & Co. KG0002022-12-15
04053755158812MINI3000 LEDHeine Optotechnik GmbH & Co. KG2,5 V WITH SCALE2022-12-15
04053755181315CONTACT PLATE DELTA 20THeine Optotechnik GmbH & Co. KGSTANDARD WITH SCALE2022-12-15
04053755181322DELTA 20THeine Optotechnik GmbH & Co. KGWITH SCALE2022-12-15
04053755181377CONTACT PLATE DELTA 20THeine Optotechnik GmbH & Co. KGSTANDARD WITHOUT SCALE2022-12-15
04053755181407DELTA 20THeine Optotechnik GmbH & Co. KGWITHOUT SCALE2022-12-15
04053755186051CONTACT PLATE iC1Heine Optotechnik GmbH & Co. KGSTANDARD2022-12-15
04053755196630DELTAoneHeine Optotechnik GmbH & Co. KGSTANDARD EDITION2022-12-12
04053755196647DELTA 30Heine Optotechnik GmbH & Co. KGWHITE EDITION2022-12-15
04053755196654DELTAoneHeine Optotechnik GmbH & Co. KGDARK NIGHT EDITION2022-12-15
04053755197101CONTACT PLATE DELTA 30Heine Optotechnik GmbH & Co. KGSTANDARD2022-12-15
04053755197118CONTACT PLATE DELTA 30Heine Optotechnik GmbH & Co. KGSMALL2022-12-15
04053755197149DELTAone CONTACT PLATEHeine Optotechnik GmbH & Co. KGSTANDARD2022-12-12
04053755197156DELTAone CONTACT PLATEHeine Optotechnik GmbH & Co. KGSMALL2022-12-12
04053755199693iC1Heine Optotechnik GmbH & Co. KG0002022-12-15
04053755199990DELTAoneHeine Optotechnik GmbH & Co. KGROSE/WHITE2022-12-12
04053755201617DELTA 30 PROHeine Optotechnik GmbH & Co. KG0832024-02-06
04053755201655DELTA 30 PROHeine Optotechnik GmbH & Co. KG0832024-02-06
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KG002026-03-02
04053755203314DELTA XHeine Optotechnik GmbH & Co. KGLED2025-12-03
04053755203321DELTA X CPPHeine Optotechnik GmbH & Co. KG002025-12-03
04053755203338DELTA X CPGHeine Optotechnik GmbH & Co. KG002025-12-03
00860013961404DermoSight DermatoscopeDEEPX HEALTH, LLCDXH-HW-1002025-06-19
00860013961411DermoSight SoftwareDEEPX HEALTH, LLCDXH-SW-1002025-06-19
04053755202928DELTAoneHeine Optotechnik GmbH & Co. KGBLACK WHITE EDITION2025-04-30
00627843751328MoleScope IIMetaOptima Technology Inc6278437513282023-02-17
00627843751342MoleScope IIMetaOptima Technology Inc6278437513422023-02-17
00627843751380MoleScope IIMetaOptima Technology Inc6278437513802023-02-17
00627843751397MoleScope IIMetaOptima Technology Inc6278437513972023-02-17
00627843751403MoleScope IIMetaOptima Technology Inc6278437514032023-02-17
00850147000018MoleScope IIMetaOptima Technology Inc8501470000182023-02-17
00850147000049MoleScope IIMetaOptima Technology Inc8501470000492023-02-17
00850147000063MoleScope IIMetaOptima Technology Inc8501470000632023-02-17
00850147000070MoleScope IIMetaOptima Technology Inc8501470000702023-02-17
00850147000087MoleScope IIMetaOptima Technology Inc8501470000872023-02-17
00850147000094MoleScope LiteMetaOptima Technology Inc8501470000942023-02-17
00850017651012DL2 Silicone SleeveDermLite LLCDLIISS2024-06-20
00850017651029MagnetiConnect for all phone/tablet adaptersDermLite LLCDLMC2024-06-20
00850017651036MagnetiConnect Adapter - 37 mmDermLite LLCDLMC-372024-06-20
00850017651043MagnetiConnect Adapter - 52 mmDermLite LLCDLMC-522024-06-20
00850017651067MagnetiConnect for Nikon 1 AW1DermLite LLCDLMC-N12024-06-20
00850017651074DL200/Lumio S Drawstring PouchDermLite LLCDSP2024-06-20
00850017651081FOTO Cable (Head to PowerPack)DermLite LLCFOTO-CABLE2024-06-20
00850017651098PowerPack ChargerDermLite LLCFOTO-CHARGER2024-06-20
00850017651104DermLite GL BatteryDermLite LLCGLB2024-06-20
00850017651111IceCap for DL200, 100-packDermLite LLCICDL200-1002024-06-20
00850017651128IceCap for DL4 & Foto X, 100-packDermLite LLCICDL4-1002024-06-20
00850017651135IceCap Covers for Nailio, 50-packDermLite LLCICNL1-502024-06-20
00850017651142DL4/DL200 USB CableDermLite LLCMUSB2024-06-20
00850017651159Foto X/GL USB-C CableDermLite LLCMUSB-C2024-06-20
00850017651166Lumio 2 BatteryDermLite LLCDLU2B2024-06-20
00850017651173Lumio 2 +2.5x Lens AccessoryDermLite LLCDLU2-12402024-06-20
00850017651180Lumio 2 495nm Longpass FilterDermLite LLCDLU2-12302024-06-20
00850017651197DL handyscope Faceplate - blankDermLite LLCFFH2-12382024-06-20
00850017651203DL handyscope Faceplate - markedDermLite LLCFFH2-12402024-06-20
00850017651210DL handyscope Soft CaseDermLite LLCFFH2-16092024-06-20
00850017651227DL handyscope BatteryDermLite LLCFFH2B2024-06-20
00850017651234DermLite GL SpacerDermLite LLCGL1-12032024-06-20
00850017651241DermLite GL ClipDermLite LLCGL1-11152024-06-20
00850017651258DLCam USB CableDermLite LLCDLCAM-USB2024-06-20
00850017651265DLCam ChargerDermLite LLCDLCAM-CH2024-06-20
00850017651272HÜD Home Skin MonitorDermLite LLCHUD22024-06-20
00850017651289Syris v900L Visualization SystemDermLite LLCv900L2024-06-20
00850017651395MagnetiConnect® for Nikon 1 SeriesDermLite LLCDLMC-N12024-06-20
00850017651401DL Connection Kit for iPhone 12DermLite LLCDLCKi122024-06-20
00850017651418DL Connection Kit for iPhone 12 ProDermLite LLCDLCKi12P2024-06-20
00850017651425DL Connection Kit for iPhone 12 Pro MaxDermLite LLCDLCKi12PM2024-06-20
00850017651432DL Connection Kit for iPhone 12 miniDermLite LLCDLCKi12MINI2024-06-20
00850017651449DermLite DL5DermLite LLCDL52024-06-20
00850017651456DermLite DL5 Charging BaseDermLite LLCDL5-CB2024-06-20
00850017651463IceCap for DL5, 25-packDermLite LLCDL5-IC252024-06-20
00850017651487DermLite DL5 RulerDermLite LLCDL5-RU2024-06-20
00850017651494DermLite DL5 Small Contact PlateDermLite LLCDL5-SCP2024-06-20
00850017651500DermLite DL5 EyepieceDermLite LLCDL5-EP2024-06-20