FDA.reportPublic FDA data

PORTALED

Primary DI
B366LED0203
Brand
PORTALED
Company
Ecleris
Model
R00
Catalog number
LED020/3
Device description
LED LIGHT SOURCE
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B366LED0203PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
LED dental light, battery-poweredA battery-powered device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity35 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
786-483-7490ytzielo@ecleris.com

Regulatory Flags#

DUNS number
043555079
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
B366U1VI360R04Procam HD CMOS IIR04U1VI3602026-05-27
B366U1VI3605PROCAM 4K USBRX1VI360/52026-05-19
B366LED0204R00PORTALEDR00LED020/42026-02-11
B366U1C200FR01MICROSCOPE ColposcopeR01U1C200F2024-02-13
B366U1C200TR01MICROSCOPE ColposcopeR01U1C200T2024-02-13
B366U1C200WR01MICROSCOPE ColposcopeR01U1C200W2024-02-13
B366HC200AR00MICROSCOPE ColposcopeR00HC200A2024-11-27
B366U1C200AR00MICROSCOPE ColposcopeR00U1C200A2024-11-25
B366U1C200FR00MICROSCOPE ColposcopeR00U1C200F2024-02-07
B366U1C200TR00MICROSCOPE ColposcopeR00U1C200T2024-02-07
B366U1C200WR00MICROSCOPE ColposcopeR00U1C200W2024-02-07
B366MC400MICROSTAR ColposcopeR02MC4002023-08-22
B366MC410MICROSTAR ColposcopeR00MC4102023-08-22
B366C100FHD1MICROSTAR ColposcopeR00C100FHD12023-08-18
B366SN0300140SinuscopeR00SN03001402023-08-18
B366SN0330140SinuscopeR00SN03301402023-08-18
B366SN0370140SinuscopeR00SN03701402023-08-18
B366SN0400175SinuscopeR00SN04001752023-08-18
B366SN0430175SinuscopeR00SN04301752023-08-18
B366SN0445175SinuscopeR00SN04451752023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
B366LED0204PORTALEDEclerisKYT2026-01-23
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00714646001375Rechargeable Light SourceBionix, LLCKYT2025-02-25
07290016672756TytoProTYTO CARE LTDKYT2024-05-26
07290016672763TytoHomeTYTO CARE LTDKYT2024-05-26
04053755201617DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
04053755201655DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
00811331011654TruBrite Adhesive Retractor LightTz Medical, Inc.KYT2023-10-20
00816835024254IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024261IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024278IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024285IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024292IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00810132041792HCSConcordance Healthcare Solutions LLCKYT2023-07-28
00810114912010SurgiTelSurgitelKYT2023-01-12
00810114912027SurgiTelSurgitelKYT2023-01-12
00810114912034SurgiTelSurgitelKYT2023-01-12
00810114912041SurgiTelSurgitelKYT2023-01-12
00810114912058SurgiTelSurgitelKYT2023-01-12
00810114912065SurgiTelSurgitelKYT2023-01-12
00634782099480Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099497Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099503Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099510Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099527Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11