FDA.reportPublic FDA data

TracLux

Primary DI
M678TLCSLS0
Brand
TracLux
Company
SUNOPTIC TECHNOLOGIES LLC
Model
TracLux-SLS
Catalog number
TLC1353-SLSU
Device description
TracLux SLS-S, Battery Operated Lightsource w/Light Clip
Published
2023-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FSZLight, Surgical, Carrier
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSZLight, Surgical, CarrierGeneral, Plastic Surgery2
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M678TLCSLS1PackageHIBCC5In Commercial Distribution
M678TLCSLS3PackageHIBCC20In Commercial Distribution
M678TLCSLS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open surgical site internal lightAn electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
094586898
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M678HLC0Sunoptic TechnologiesHeadlight Cables2017-05-09
M678FOC0Sunoptic TechnologiesFiberoptic Cables2017-05-09
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
M678HLM0Sunoptic TechnologiesHeadlights Molded2017-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194665008857A-decA-DEC, INC.FTD2026-05-07
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04048675754947PolarisDrägerwerk AG & Co. KGaAFTD2025-11-05
03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00816744027230Myriad-LXNICO CORPORATIONFTD2025-08-11
00860013851576Nova 3QED, INC.FTD2025-05-22
00860013851507BeamerQED, INC.FTD2025-05-21
00860013851514Nova 300QED, INC.FTD2025-05-21
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