FDA.reportPublic FDA data

BostonSight SCLERAL

Primary DI
10850085735215
Brand
BostonSight SCLERAL
Company
The Boston Foundation For Sight, Inc.
Model
21
Catalog number
n/a
Device description
BostonSight SCLERAL for daily wear, fabricated from Acuity 200 (fluoroxyfocon A) - Clear
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQDLens, Contact (Other Material) - Daily

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQDLens, Contact (Other Material) - DailyOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241571000BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight2024-08-14HQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850085735215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085008573521510850085735215

GMDN Terms#

Term, Definition table
TermDefinition
Rigid-gas-permeable corrective contact lens, daily-wear, non-customizedA prefabricated (non-customized) rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-888-725-3725xx@xx.xx

Regulatory Flags#

DUNS number
849472717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850085735024BostonSight SCLERAL02N/A2026-07-21
10850085735048BostonSight SCLERAL04N/A2026-07-21
10850085735055BostonSight SCLERAL05N/A2026-07-21
10850085735062BostonSight SCLERAL06n/a2026-07-21
10850085735079BostonSight SCLERAL07n/a2026-07-21
10850085735086BostonSight SCLERAL08n/a2026-07-21
10850085735109BostonSight SCLERAL10n/a2026-07-21
10850085735123BostonSight SCLERAL12n/a2026-07-21
10850085735130BostonSight SCLERAL13n/a2026-07-21
10850085735147BostonSight SCLERAL14n/a2026-07-21
10850085735154BostonSight SCLERAL15n/a2026-07-21
10850085735161BostonSight SCLERAL16n/a2026-07-21
10850085735178BostonSight SCLERAL17n/a2026-07-21
10850085735185BostonSight SCLERAL18n/a2026-07-21
10850085735192BostonSight SCLERAL19n/a2026-07-21
10850085735208BostonSight SCLERAL20n/a2026-07-21
10850085735239BostonSight PROSE02n/a2026-07-21
10850085735253BostonSight PROSE04n/a2026-07-21
10850085735260BostonSight PROSE05n/a2026-07-21
10850085735277BostonSight PROSE06n/a2026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850085735024BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735048BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735055BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735062BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735079BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735086BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735109BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735123BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735130BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735147BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735154BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735161BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735178BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735185BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735192BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735208BostonSight SCLERALThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735239BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735253BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735260BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735277BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735284BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735291BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735314BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735338BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735345BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735352BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735369BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735376BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735383BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21
10850085735390BostonSight PROSEThe Boston Foundation For Sight, Inc.HQD2026-07-21