Danker Silicone Lens (Dimefocon-A)
PMA P790010
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP790010 | Date25 Aug 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Lenses, soft contact, extended wear
- PMA Number
- FDA Product Code
- LPM
- Device Class
- Class III
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Overview
AI-generated summary, 18 Sep 2026
The Danker Silicone Lens (Dimefocon-A) is a contact lens made from silicone material, designed for daily wear. It is classified as a 'Lens, Contact (Other Material) - Daily' under ophthalmic device regulations.
This device is supplied as a reusable or single-use contact lens for ophthalmic use, with authorisation via FDA PMA P790010. It is manufactured by Ciba Vision Corporation and intended for daily wear as specified in its generic name and regulatory classification.
Other devices from Ciba Vision Corporation
Questions
AI-generated answers, 18 Sep 2026
What material is the Danker Silicone Lens (Dimefocon-A) made from?
The Danker Silicone Lens (Dimefocon-A) is made from silicone material, as indicated in its product name and specifications.
Who manufactures the Danker Silicone Lens (Dimefocon-A)?
The Danker Silicone Lens (Dimefocon-A) is manufactured by Ciba Vision Corporation, as stated in the manufacturer and applicant fields.
What is the regulatory classification and authorisation for the Danker Silicone Lens (Dimefocon-A)?
The device is classified as a Class II ophthalmic device with FDA PMA authorisation under number P790010, and its generic name is 'Lens, Contact (Other Material) - Daily'.