FDA.reportPublic FDA data

Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer

Primary DI
M678DPLS300W0
Brand
Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer
Company
SUNOPTIC TECHNOLOGIES LLC
Model
DPLS-01, DPLS-03
Device description
Xenon Lightsource, 300 Watt, Digital
Published
2022-02-25
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
FSSLight, Surgical, Floor Standing
HBIIlluminator, Fiberoptic, Surgical Field

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSSLight, Surgical, Floor StandingGeneral, Plastic Surgery2
HBIIlluminator, Fiberoptic, Surgical FieldGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M678DPLS300W0PrimaryHIBCC0

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9047377611Robert.Archie@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
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
M678HLM0Sunoptic TechnologiesHeadlights Molded2017-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770419067Bausch + LombBausch & Lomb IncorporatedHBI2026-04-30
00855373008036NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
00855373008043NICO Corporation SUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
M678NN70640NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
M678NN90100NICOSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
00857580006829Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2025-02-26
10686864056819Medicom SafeMaskAMD Medicom IncFSS2025-01-23
20686864056816Medicom SafeMaskAMD Medicom IncFSS2025-01-23
03700712412029Maquet RoliteMAQUET SASFSS2024-11-07
00857580006812Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2024-10-15
04250613849282DM MS Sim.LED ExL DES.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849305MS Sim.LED OpL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849329MS Sim.LED OpL wDBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849367MS Sim.LED OpL USS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849404DM MS Sim.LED ExL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
03700712432508Maquet RoliteMAQUET SASFSS2024-06-20
03700712432522Maquet RoliteMAQUET SASFSS2024-06-20
00816744027728NICO Myriad SPECTRANICO CORPORATIONHBI2024-06-07
00857580006805Fiber Optic Light CableGULF FIBEROPTICS, INC.HBI2024-06-07
03700712432515Maquet RoliteMAQUET SASFSS2024-02-02
14026704741837PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
24026704741834PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
03700712432539Maquet RoliteMAQUET SASFSS2023-12-15
00816835024216OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816835024223OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816835024230OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
00816835024247OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024215OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024222OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02
01816835024239OptiLux LED IlluminatorMedical Illumination International Inc.HBI2023-10-02