FDA.reportPublic FDA data

FIBEROPTIC HEADLUX

Primary DI
B366HDL200
Brand
FIBEROPTIC HEADLUX
Company
Ecleris
Model
R00
Catalog number
HDL200
Device description
HEADLIGHT
Published
2022-06-10
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
FCTHeadlight, Fiberoptic Focusing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCTHeadlight, Fiberoptic FocusingOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B366HDL200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

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
00860013851521Altair HI 2QED, INC.FCT2025-05-21
00860013851538Altair SAQED, INC.FCT2025-05-21
00840183529192BR Surgical, LLCBR Surgical, LLCFCT2024-12-02
00840183500559BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183501136BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00840183512989BR Surgical, LLCBR Surgical, LLCFCT2024-07-22
00816835023967IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023974IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023981IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023998IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024018IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024025IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024032IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024056Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
00816835024063Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
00816835023950IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023966IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023973IsoLED Mini LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023980IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
01816835023997IsoLED II LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024017IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024024IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024031IsoLED Plus+ LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024055Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
01816835024062Magnum LED HLMedical Illumination International Inc.FCT2023-10-02
00862658000326Fiberoptics Technology IncFIBEROPTICS TECHNOLOGY, INC.FCT2021-07-26
04055207008751NARichard Wolf GmbHFCT2018-10-17
M678HL0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
M678HLM0Sunoptic TechnologiesSUNOPTIC TECHNOLOGIES LLCFCT2017-05-09
00841645132004ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFCT2016-09-26