Tresoft Ocufilcon Soft Hydrophilic Contact Lens
PMA P870079
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP870079 | Date26 May 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- 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
- S001 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Tresoft Ocufilcon Soft Hydrophilic Contact Lens is a soft contact lens designed for daily wear. It is made of hydrophilic material to provide comfort for users who require vision correction.
This lens is supplied as a sterile, single-use device and should be stored according to manufacturer instructions. The device is authorized by the FDA with PMA number P870079 and is classified as a Class II medical device under product code LPL.
Other devices from United Contact Lens, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Tresoft Ocufilcon Soft Hydrophilic Contact Lens used for?
The Tresoft Ocufilcon Soft Hydrophilic Contact Lens is designed for daily wear to provide vision correction for users. It is made of hydrophilic material to ensure comfort during wear.
How is the Tresoft contact lens supplied and what is its sterility status?
The lens is supplied as a sterile, single-use device. It should be stored according to the manufacturer's instructions to maintain its sterility and effectiveness.
Is the Tresoft contact lens reusable or single-use only?
The Tresoft Ocufilcon Soft Hydrophilic Contact Lens is a single-use device and should not be reused. It is designed for daily wear and should be discarded after each use.
What is the regulatory status of the Tresoft contact lens?
The device is authorized by the FDA with PMA number P870079 and is classified as a Class II medical device under product code LPL. It received FDA approval on May 26, 1989.