FDA.reportPublic FDA data

Post Op Eyewear

Primary DI
00818806021767
Brand
Post Op Eyewear
Company
RXSIGHT, INC.
Model
62027
Device description
Post Op Spectacles, +1.50D
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818806021767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818806021767008188060217678188060217670818806021767

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
052054413
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818806022481Light Adjustable Lens (LAL)60005-30022025-10-17
00818806022498Light Adjustable Lens (LAL)60005-30012025-10-17
00818806022504Light Adjustable Lens (LAL)60005-30002025-10-17
00818806022511Light Adjustable Lens (LAL)60005-30102025-10-17
00818806022528Light Adjustable Lens (LAL)60005-30202025-10-17
00818806022535Light Adjustable Lens (LAL)60005-30302025-10-17
00818806021750Post Op Eyewear620262025-09-05
00818806021774RxSight Contact Lens62020-0022025-09-05
00818806020852Light Adjustable Lens (LAL)60007-00302024-12-04
00818806020869Light Adjustable Lens (LAL)60007-00202024-12-04
00818806020951Light Adjustable Lens (LAL)60007-00102024-12-04
00818806021484Light Adjustable Lens (LAL)60007-00002024-12-04
00818806021736Light Adjustable Lens (LAL)60007-00012024-12-04
00818806021743Light Adjustable Lens (LAL)60007-00022024-12-04
00818806020036RxSight Light Adjustable Lens (RxLAL)60005-21002019-04-01
00818806020043RxSight Light Adjustable Lens (RxLAL)60005-21102019-04-01
00818806020050RxSight Light Adjustable Lens (RxLAL)60005-21202019-04-01
00818806020067RxSight Light Adjustable Lens (RxLAL)60005-21302019-04-01
00818806020074RxSight Light Adjustable Lens (RxLAL)60005-21402019-04-01
00818806020081RxSight Light Adjustable Lens (RxLAL)60005-21502019-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973541157797SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158227SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158234SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158241SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158258SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158265SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158272SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158289SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158296SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158302SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
00754317216479Ernest HemingwayNew York EyeHQY2026-08-17
00754317216486Ernest HemingwayNew York EyeHQY2026-08-17
00754317218022Ernest HemingwayNew York EyeHQY2026-08-17
00754317218039Ernest HemingwayNew York EyeHQY2026-08-17
00754317228151Valerie SpencerNew York EyeHQY2026-08-17
00754317228618Marc HunterNew York EyeHQY2026-08-17
00754317228625Marc HunterNew York EyeHQY2026-08-17
00754317228632Marc HunterNew York EyeHQY2026-08-17
00754317228649Marc HunterNew York EyeHQY2026-08-17
00754317228656Valerie SpencerNew York EyeHQY2026-08-17
00754317228663Valerie SpencerNew York EyeHQY2026-08-17
00754317228670Valerie SpencerNew York EyeHQY2026-08-17
00754317228687Valerie SpencerNew York EyeHQY2026-08-17
00754317228694Valerie SpencerNew York EyeHQY2026-08-17
00754317228731Ernest HemingwayNew York EyeHQY2026-08-17
00754317228748Ernest HemingwayNew York EyeHQY2026-08-17
08800348923403Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923410Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923427Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923441Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14