FDA.reportPublic FDA data

Sunoptic Technologies

Primary DI
M678LED500
Brand
Sunoptic Technologies
Company
SUNOPTIC TECHNOLOGIES LLC
Model
LED050 1000 and 2000 Lightsources
Device description
LED 50 watt 1000 and 2000 lightsources
Published
2017-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCWLight Source, Fiberoptic, Routine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M678LED500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Contacts#

Phone, Email table
PhoneEmail
9047377611janice.lee@sunoptictech.com

Regulatory Flags#

DUNS number
094586898
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M678HLC0Sunoptic TechnologiesHeadlight Cables2017-05-09
M678FOC0Sunoptic TechnologiesFiberoptic Cables2017-05-09
M678TLCSLS0TracLuxTracLux-SLSTLC1353-SLSU2023-05-29
M678TX0Sunoptic Technologies Tx series Xenon Lightsource2017-05-09
M678DPLS300W0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerDPLS-01, DPLS-032022-02-25
00855373008036NICO Myriad-LXTx350ANN-70642025-06-03
00855373008043NICO Corporation STX0350NN-90102025-06-03
00855373008029StrykerLLS-050INV-LLS-2000HPAK2025-05-15
M678TLS0TracLuxTLS2575, TLS25150TLS2550, TLS251502025-05-08
M678NN70640NICO Myriad-LXTX350ANN-70642025-03-27
M678NN90100NICONN-9010NN-90102025-03-27
M678SLS0Sunoptic TechnologiesRover Lightsource series2018-06-27
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerROVER SLSROVER SLS-S2023-03-01
M678HHR0TRACLUXHHRTLH001, TLH002, TLB2575, TLB251502021-11-05
M678DLS0Sunoptic TechnologiesRover Lightsource series2018-06-27
M678DLS10Sunoptic TechnologiesRover Lightsource series2018-06-27
M678ROVER0Sunoptic TechnologiesRover Lightsource series2017-05-09
M678SLS10Sunoptic TechnologiesRover Lightsource series2018-06-27
M678CS0Sunoptic TechnologiesCamera System2017-05-09
M678HL0Sunoptic TechnologiesHeadlights2017-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047788607GimmiGimmi GmbHFCW2026-03-04
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFCW2025-06-11
00855373008029StrykerSUNOPTIC TECHNOLOGIES LLCFCW2025-05-15
04049047788522GimmiGimmi GmbHFCW2025-03-20
04048551366813n.a.Karl Storz GmbH & Co. KGFCW2024-11-28
00840183528577BR Surgical, LLCBR Surgical, LLCFCW2024-10-24
04049197465007RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
04049197465069RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFCW2024-09-20
00840183507763BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
00840183527341BR Surgical, LLCBR Surgical, LLCFCW2024-07-22
04250480109045N/ASCHÖLLY FIBEROPTIC GmbHFCW2023-10-24
04961333071333PENTAXHOYA CORPORATIONFCW2023-07-31
04961333238088PENTAXHOYA CORPORATIONFCW2023-07-31
M678SLSS0Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM CustomerSUNOPTIC TECHNOLOGIES LLCFCW2023-03-01
00840319710616Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710623Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710630Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710647Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710654Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710661Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710678Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710685Hayden MedicalHayden Medical, Inc.FCW2022-07-28
00840319710692Hayden MedicalHayden Medical, Inc.FCW2022-07-28
G043MLGA4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGA4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGO4X7ST0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7AC0BEARBear-Ent, LLCFCW2022-05-19
G043MLGS4X7ST0BEARBear-Ent, LLCFCW2022-05-19
07613327051568NASTRYKER CORPORATIONFCW2021-07-07