Confocal Optical Imaging

Product Code: OWN

Gastroenterology/Urology Medical Laser Products

Definition: Collection Of Light Signals For Visualization Of Cellular Microstructures.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 876.1500


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OWN

5465Confocal Optical ImagingEndoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

5465Confocal Optical ImagingEndoscope And Accessories.

Pre-market Notifications for OWN

K223020VS3-Iridium System (VS3-IR)Visionsense Ltd.
K221611780 Nm L11 LED Light Source With AIMStryker
K212322Cellvizio I.V.E. System With Confocal MiniprobesMauna Kea Technologies
K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.
K202925KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy_America, Inc.
K202244SPY-PHI System With SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies ULC (now A Part Of Stryker)
K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies ULC. (now A Part Of Stryker)
K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera HeadOlympus Medical Systems Corp.
K193416Cellvizio I.V.E. With Confocal MiniprobesMauna Kea Technologies
K192292L10 LED Light Source With AIM, L11 LED Light Source With AIM, AIM SafeLight CableStryker
K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies ULC. (now A Part Of Stryker)
K191851VS3-IRMedtronic
K191144Cellvizio 100 Series System With Confocal MiniprobesMauna Kea Technologies
K191046L10 LED Light Source With AIM, L11 LED Light Source With AIMStryker
K190729SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies ULC. (now A Part Of Stryker)

Global Unique Device Identification Database

00858701006193Confocal Optical Imaging
07613327455915Confocal optical imaging
07613327174359Confocal optical imaging
07613327174328Confocal optical imaging
07613327063912Confocal optical imaging
07613327063905Confocal optical imaging
07613327059373Confocal optical imaging
07613327059342Confocal optical imaging
07613327051674Confocal optical imaging
07613327051377Confocal optical imaging
04582389010093Confocal Optical Imaging
04582389010031Confocal Optical Imaging
B475PVUETSC101Confocal Optical Imaging
B475PVUECOH100Confocal Optical Imaging
B475PVUECCB100Confocal Optical Imaging

Maude Adverse Events

PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2020-03-04
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2020-03-04
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2020-02-06
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2020-02-06
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2020-02-06
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2020-02-06
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2020-01-30
HOPKINS STRAIGHT FORWARD TELESCOPE 30?KARL STORZ SE & CO. KG2020-01-15
HOPKINS STRAIGHT FORWARD TELESCOPE 30?KARL STORZ SE & CO. KG2020-01-15
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2020-01-15
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2020-01-08
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2019-12-19
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2019-12-19
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2019-12-19
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2019-12-19
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2019-12-16
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-12-16
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-12-16
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-12-16
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-12-12
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-12-12
SPY-PHI HANDHELD IMAGERNOVADAQ TECHNOLOGIES2019-12-09
PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05MSTRYKER ENDOSCOPY-SAN JOSE2019-11-27
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-11-07
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-11-07
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-11-07
PKG, 1588 AIM CAMERA CONTROL UNIT (CCU)STRYKER ENDOSCOPY-SAN JOSE2019-10-30
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-10-28
PKG, 1588 AIM CAMERA CONTROL UNIT (CCU)STRYKER ENDOSCOPY-SAN JOSE2019-10-15
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-10-15
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-10-15
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-10-10
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-10-07
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-10-07
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-10-07
D-LIGHT P HIGH POWER LIGHT UNIT FOR AFKARL STORZ SE & CO. KG2019-10-03
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-10-01
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-09-24
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-09-11
AIM HD LAPAROSCOPE, AUTOCLAVABLE, 5.4MM X 30?, 30CMSTRYKER ENDOSCOPY-SAN JOSE2019-09-03
PKG, 1588 AIM CAMERA CONTROL UNIT (CCU)STRYKER ENDOSCOPY-SAN JOSE2019-08-29
PKG, L11 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-08-28
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-08-27
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-08-22
AIM HD LAPAROSCOPE, AUTOCLAVABLE, 10MM X 0?, 33CMSTRYKER ENDOSCOPY-SAN JOSE2019-08-13
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-08-13
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-07-25
PKG, 1588 AIM CAMERA CONTROL UNIT (CCU)STRYKER ENDOSCOPY-SAN JOSE2019-07-25
PKG, L10 LED LIGHT SOURCE WITH AIMSTRYKER ENDOSCOPY-SAN JOSE2019-07-25
PKG, 1588 AIM CAMERA CONTROL UNIT (CCU)STRYKER ENDOSCOPY-SAN JOSE2019-07-24
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