Digital Prism Correction Feature (DPCF)

Basic Information

• Brand Name: Digital Prism Correction Feature (DPCF)
• Primary DI: 00195949948411
• Version / Model: Feature version 1.X
• Company Name: APPLE INC.
• Labeler DUNS: 060704780
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-11
• Public Version: 1
• Public Version Date: 2025-09-19
• Public Version Status: New
• Public Device Record Key: f12323d7-0fe5-4a4f-8a5c-ef2cc35dfeb9

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SCW	Digital Prismatic Correction	Ophthalmic	886.1655	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32718	Fresnel prism	A thin plastic sheet with embossed rulings, which provides the optical effect of a prism, intended to be applied to spectacle lenses to give a prismatic effect typically to manage strabismus or other eye muscle dysfunction. The device may also be temporarily applied to spectacle lenses to determine how a patient might respond to prismatic power in their eye glasses.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195949948411	GS1

Premarket Submissions

Submission Number	Supplement Number
K250143	000