FDA.reportPublic FDA data

Right Light

Primary DI
D867RLH0
Brand
Right Light
Company
Xemax Surgical Products Inc
Model
RLH
Catalog number
RLH
Device description
Battery powered head lamp.
Published
2023-06-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D867RLH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic dental lightA mains electricity (AC-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 fibreoptic cable to illuminate the site of a dental examination or procedure. The illumination is produced by the light source of the device, a dedicated light bulb, and is transmitted via the fibreoptic cable which is attached to a dental handpiece held, or a headband worn, by dental staff. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
804495695
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D867CLEG0Etchant GelCLEGCLEG2017-05-22
D867CLEGS0Etchant Gel SyringeCLEGSCLEGS2017-05-22
D867CLABC0Aqua Bond CompositeCLABCCLABC2017-05-22
D867CLQSP0Quick Set Paste A & BCLQSPCLQSP2017-05-22
D867CLQSPA0Quick Set Paste ACLQSPACLQSPA2018-05-31
D867CLQSPB0Quick Set Paste BCLQSPBCLQSPB2018-05-31
D867CLABP0Aqua Bond SealantCLABPCLABP2017-05-22
D867CSII1000C-SpongeIICSII1002022-08-08
D867CSIII1000C-SpongeIIICSIII1002022-08-08
D867CSIV1000C-SpongeIVCSIV1002022-08-08
D867CSP500C-SpongePedoCSP502022-08-08
D867CSR1000C-SpongeRegularCSR1002022-08-08
D867ELILG0Elbow ImmobilizerELILGELILG2023-06-12
D867ELISM0Elbow Immobilizer PedoELISMELISM2023-06-12
D867OSSF0Osseo II Bone TrapOSSFOSSF2023-06-12
D867CL36005Cusp-Lok 360CL360052022-09-09
D867CL36010Cusp-Lok 360CL360102022-09-09
D867CLCMLP05Cusp-Lok CMLPCLCM05LP2022-09-09
D867CLCMLP10Cusp-Lok CMLPCLCM10LP2022-09-09
D867CLCMR05Cusp-Lok CMRCLCM05R2022-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B366LED0203PORTALEDEclerisKYT2025-11-21
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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
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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
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00634782099480Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
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00634782099503Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099510Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099527Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11