FDA.reportPublic FDA data

Righton

Primary DI
04562230695563
Brand
Righton
Company
RIGHT MFG. CO., LTD.
Model
Aspherical Lens 20D
Catalog number
RBA111AA
Published
2022-11-30
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
HJLLens, Condensing, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJLLens, Condensing, DiagnosticOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562230695563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562230695563045622306955634562230695563

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic diagnostic condensing lensAn ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
713383495
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04562230698458RightonRetinomax K+ScreeenRDA1152AA2022-12-09
04562230698502RightonRetinomax K+ScreeenRDA1182AA2022-12-09
04562230698557RightonRetinomax K+ScreeenRDA1172AA2022-12-09
04562230698755RightonRetinomax K+ScreeenRDA1152BA2022-12-09
04562230698809RightonRetinomax K+ScreeenRDA1182BA2022-12-09
04562230698854RightonRetinomax K+ScreeenRDA1172BA2022-12-09
04580606430020RightonRetinomax 5RDA2112AA2022-12-09
04580606430075RightonRetinomax 5RDA2142AA2022-12-09
04580606430129RightonRetinomax 5RDA2132AA2022-12-09
04580606430174RightonRetinomax K-plus5RDA2152AA2022-12-09
04580606430228RightonRetinomax K-plus5RDA2182AA2022-12-09
04580606430273RightonRetinomax K-plus5RDA2172AA2022-12-09
04580606430327RightonRetinomax 5RDA2112BA2022-12-09
04580606430372RightonRetinomax 5RDA2142BA2022-12-09
04580606430426RightonRetinomax 5RDA2132BA2022-12-09
04580606430471RightonRetinomax K-plus5RDA2152BA2022-12-09
04580606430525RightonRetinomax K-plus5RDA2182BA2022-12-09
04580606430570RightonRetinomax K-plus5RDA2172BA2022-12-09
04562230696607RightonSpeedy-K2RDA811AB2022-11-30
04562230698298RightonRetinomax ScreeenRDA1112AA2022-11-30

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Primary DI, Brand, Company table
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0081160801984078D Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
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00811608019864Super 66® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019871SuperField® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
00811608019888Digital Wide Field® Limited Edition #2VOLK OPTICAL INC.HJL2025-08-01
0081160801476020D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801477728D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014784Pan Retinal 2.2 Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014791Digital ClearField Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801480778D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
0081160801481490D Limited EditionVOLK OPTICAL INC.HJL2024-09-26
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00811608014838SuperField® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
00811608014845Digital Wide Field® Limited EditionVOLK OPTICAL INC.HJL2024-09-26
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