Permatint Soft Contact Lenses
PMA P820059
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP820059 | Date10 Dec 1984 | 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- Withdrawn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
- Full name
- Permatint(R)
- Generic Name
- Lenses, soft contact, daily wear
- PMA Number
- FDA Product Code
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S002
Overview
AI-generated summary, 18 Sep 2026
Permatint Soft Contact Lenses are classified as Lenses, Soft Contact, Daily Wear, designed for ophthalmic use. These lenses are intended to correct vision and may be used for cosmetic purposes, providing a comfortable and clear visual experience for daily wear.
These lenses are supplied in sterile, single-use packaging and are regulated under FDA_PMA with PMA number P820059. They are intended for use in clinical settings by trained professionals and are available in multiple registration numbers and product codes, including LPL. No MRI safety or reusable specifications are indicated in the data.
Other devices from Wesley Jessen Corp.
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses reusable or intended for single-use only?
Permatint Soft Contact Lenses are supplied in sterile, single-use packaging, meaning each lens is designed for one-time wear only. This ensures hygiene and reduces the risk of infection, aligning with daily-wear contact lens standards.
What types of vision correction or cosmetic purposes can these lenses address?
Permatint Soft Contact Lenses are classified as daily-wear soft contact lenses and are intended to correct vision. They may also be used for cosmetic purposes, such as altering eye appearance, while providing a comfortable and clear visual experience.
How are these lenses regulated, and what does that mean for clinical use?
Permatint Soft Contact Lenses are regulated under an FDA Premarket Approval (PMA) with PMA number P820059. This means they have undergone rigorous review to ensure safety and effectiveness for ophthalmic use, and they are intended for clinical settings by trained professionals only.
Are there multiple sizes or models available for these contact lenses?
Yes, Permatint Soft Contact Lenses are available in multiple registration numbers and product codes, indicating a variety of sizes and models to accommodate different prescription needs and eye measurements. These variations ensure a fit tailored to individual patients.
How should these lenses be stored before use, and what are the packaging specifications?
Permatint Soft Contact Lenses are supplied in sterile, single-use packaging, which means they should be stored in their original, unopened packaging until ready for use. The sterile packaging ensures the lenses remain uncontaminated and safe for one-time wear.