FDA.reportPublic FDA data

Confocal Microprobe Imaging System

Primary DI
06971679949898
Brand
Confocal Microprobe Imaging System
Company
Wuxi Hisky Medical Technologies Co.,Ltd.
Model
BrightP280
Published
2025-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
OWNConfocal Optical Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243711000Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);Wuxi Hisky Medical Technologies Co., Ltd.2025-07-24OWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971679949898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971679949898069716799498986971679949898

GMDN Terms#

Term, Definition table
TermDefinition
Confocal endomicroscopy systemAn assembly of mains electricity-powered (AC-powered) devices designed to visualize microscopic cellular and tissue structures during an endoscopic, interventional or surgical procedure to provide real-time images to facilitate further treatment planning. It is based on fluorescence confocal microscopy and typically consists of the confocal laser scanning unit, hand/foot controls, an endoscopic fibreoptic probe, and an image processing and display unit for visualization and/or recording.

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
544348534
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971679949782Confocal Microprobe Imaging SystemBrightP9802025-08-14
06971679949799Confocal Microprobe Imaging SystemBrightP9602025-08-14
06971679949805Confocal Microprobe Imaging SystemBrightP9002025-08-14
06971679949812Confocal Microprobe Imaging SystemBrightP8802025-08-14
06971679949829Confocal Microprobe Imaging SystemBrightP8602025-08-14
06971679949836Confocal Microprobe Imaging SystemBrightP7802025-08-14
06971679949843Confocal Microprobe Imaging SystemBrightP7502025-08-14
06971679949850Confocal Microprobe Imaging SystemBrightP6802025-08-14
06971679949867Confocal Microprobe Imaging SystemBrightP6602025-08-14
06971679949874Confocal Microprobe Imaging SystemBrightP6002025-08-14
06971679949881Confocal Microprobe Imaging SystemBrightP5802025-08-14
06971679949904Confocal Microprobe Imaging SystemBrightP2002025-08-14
06971679949911Confocal Microprobe Imaging SystemBrightP1602025-08-14
06971679949928Confocal Microprobe Imaging SystemBrightP1002025-08-14
06971679949935Confocal Microprobe Imaging SystemBrightX662025-08-14
06971679948945Shear Wave Quantificational Ultrasound Diagnostic SystemMini9902025-08-05
06971679948952Shear Wave Quantificational Ultrasound Diagnostic SystemMini7902025-08-05
06971679948969Shear Wave Quantificational Ultrasound Diagnostic SystemMini7802025-08-05
06971679948976Shear Wave Quantificational Ultrasound Diagnostic SystemMini5602025-08-05
06971679948983Shear Wave Quantificational Ultrasound Diagnostic SystemMini3002025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403001ActivSight Light EngineActiv Surgical, Inc.OWN2026-05-26
00850016403018Activ Sight C-Mount Imaging ModuleActiv Surgical, Inc.OWN2026-05-26
00850016403025ActivSIght Light GuideActiv Surgical, Inc.OWN2026-05-26
00850016403032ActivSight Light Cable Adapter - StrykerActiv Surgical, Inc.OWN2026-05-26
00850016403087ActivSight Light Cable Adapter - StorzActiv Surgical, Inc.OWN2026-05-26
00850016403094ActivSight Integrated Imaging ModuleActiv Surgical, Inc.OWN2026-05-26
00850016403124ActivSight Light Cable Adapter - Olympus IRActiv Surgical, Inc.OWN2026-05-26
00850016403162ActivSight Light Cable Adapter - Storz IRActiv Surgical, Inc.OWN2026-05-26
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-11-21
06971679949782Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949799Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949805Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949812Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949829Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949836Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949843Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949850Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949867Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949874Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949881Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949904Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949911Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949928Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
06971679949935Confocal Microprobe Imaging SystemWuxi Hisky Medical Technologies Co.,Ltd.OWN2025-08-14
04048551418123n.a.Karl Storz GmbH & Co. KGOWN2025-08-11
04250480104200NASCHÖLLY FIBEROPTIC GmbHOWN2025-06-11
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.OWN2025-04-17
04048551411704NAKarl Storz GmbH & Co. KGOWN2025-03-27