Tri Pol Soft Contact Lenses
PMA N18162
Active
Valid until
No expiry
FDA recalls
None foundDocuments
PMA N18162
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN18162 | Date31 Aug 1979 | 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- Withdrawn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
- Tri Pol
- Trade Name
- Aqua-Soft (Deltafilc
- 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
The Tri Pol Soft Contact Lenses are classified as Lenses, Soft Contact, Daily Wear, designed for corneal refractive correction. These lenses are intended for daily wear and provide optical correction for vision impairments, offering a comfortable and non-invasive solution for patients requiring corrective eyewear.
These lenses are supplied as single-use, non-sterile products intended for ophthalmic use only. They are regulated under the FDA PMA (Premarket Approval) process and fall under Device Class II (regulation number 886.5925). The product is manufactured by Aquarius Soft Lens, Inc., and is distributed in various prescription strengths and sizes as indicated by the registration numbers. No MRI safety information or reusable specifications are provided.
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses designed for extended wear, or are they meant to be worn only during the day?
The Tri Pol Soft Contact Lenses are explicitly designed for daily wear only, meaning they are intended to be worn during waking hours and removed before sleep. This classification ensures comfort and safety for patients who require corrective vision support throughout the day without the risks associated with overnight wear.
How are these lenses supplied, and do they require any special handling before use?
The Tri Pol Soft Contact Lenses are supplied as single-use, non-sterile products. Since they are non-sterile, they should be handled with care to avoid contamination. Each lens is intended for one-time use only, so no reprocessing or reuse is recommended. Proper hygiene practices, such as washing hands before handling, are advised.
What prescription strengths and sizes are available for these contact lenses?
The Tri Pol Soft Contact Lenses are available in a variety of prescription strengths and sizes, as indicated by the listed registration numbers (e.g., 3015533540, 3012546757, etc.). These numbers correspond to specific prescriptions and base curves tailored to different corneal shapes and refractive errors. The exact details of each prescription would be provided by the manufacturer or distributor upon ordering.
Can these lenses be reused after removal, or are they intended for one-time use?
The Tri Pol Soft Contact Lenses are intended for single-use only and are not designed for reuse. This is explicitly stated in the product description, emphasizing that each lens is meant to be discarded after one use to maintain safety and hygiene standards for the patient.
What regulatory pathway was followed for approval of these contact lenses, and what class do they fall under?
The Tri Pol Soft Contact Lenses were approved through the FDA Premarket Approval (PMA) process, which is a rigorous regulatory pathway for devices deemed to carry higher risks. They are classified under Device Class II (regulation number 886.5925), indicating a balance of risk and benefit that requires additional scrutiny beyond general controls. This classification aligns with their role as corrective eyewear intended for daily use.