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BostonSight SCLERAL 12

by The Boston Foundation For Sight, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10850085735123 UDI-DI Date21 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BostonSight SCLERAL
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
Model / Ref / Catalog
12
Primary DI / UDI-DI
10850085735123
510(k) Number
FDA Product Code
HQD
GMDN Term
Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
Device Class
Class II
Regulation Number
886.5916
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K241571)

Show all (12)

Other devices from The Boston Foundation For Sight, Inc.

See all devices from The Boston Foundation For Sight, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No