Permalens Perfilcon Hydrophilic Contact Lens
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- PERMALENS EXTENDED WEAR CONTACT LENS FDA PMA
- Generic Name
- Lenses, soft contact, extended wear FDA PMA
Identifiers
- PMA Number
- P780010 FDA PMA
- FDA Product Code
- LPM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5925 FDA PMA
- Regulation Number
- 886.5925 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S013 FDA PMA
The Permalens Perfilcon Hydrophilic Contact Lens is a soft contact lens designed for extended wear. It is classified as an ophthalmic device intended to provide vision correction for patients requiring extended wear contact lenses.
This device is manufactured by CooperVision, Inc. and is authorized for use under FDA PMA regulations. It is categorized under the regulation number 886.5925 for soft contact lenses.
Frequently asked questions
What type of device is the Permalens contact lens?
The Permalens is a soft, hydrophilic contact lens designed for extended wear, categorized as an ophthalmic device.
Who is the manufacturer of the Permalens contact lens?
The Permalens contact lens is manufactured by CooperVision, Inc., based in Pleasanton, California.
Is the Permalens contact lens FDA authorized?
Yes, the Permalens contact lens is authorized for use under an FDA Premarket Approval (PMA) process, specifically under PMA number P780010.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P780010 | Class III | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA PMA P780010 24 fields · synced Sep 18, 2026