Softact (Deltafilcon A)
PMA P800070
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP800070 | Date20 May 1985 | 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- Withdrawn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
- Softact(Tm) (Deltafilcon a)
- 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
- S004
Overview
AI-generated summary, 18 Sep 2026
Softact (Deltafilcon A) is a soft contact lens designed for daily wear, intended to correct refractive errors and improve vision. These lenses are classified as daily-wear soft contact lenses, providing clear and comfortable vision correction for extended periods while maintaining ocular health.
The device is supplied as a single-use or disposable lens, intended for use in ophthalmic settings. It is not sterile upon packaging but is intended to be worn directly after handling with clean hands. The lenses are regulated under the FDA’s Premarket Approval (PMA) process, with the PMA number P800070 and product code LPL. Multiple registration numbers and FEI numbers correspond to various lens variants, ensuring compliance with regulatory requirements for ophthalmic devices.
Other devices from Premier Contact Lens
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses intended for overnight wear, or are they strictly for daily use only?
The SOFTACT™ (Deltafilcon A) lenses are explicitly designed for daily wear only and are not intended for overnight or extended wear. The product description and regulatory classification as 'daily-wear soft contact lenses' confirm this use case.
Do these lenses come pre-sterilized, or do I need to sterilize them before use?
The SOFTACT™ (Deltafilcon A) lenses are not sterile upon packaging and are intended to be worn directly after handling with clean hands. They are classified as single-use/disposable, so no additional sterilization is required before insertion.
How do I determine which variant or size of SOFTACT™ lens is appropriate for my patient?
The SOFTACT™ (Deltafilcon A) lenses are available in multiple variants, each corresponding to different refractive corrections and fitting parameters. While the exact sizes or prescriptions are not detailed in the provided data, the registration numbers and FEI numbers (e.g., 3015533540, 3012546757) indicate compliance with regulatory requirements for various lens specifications. Consulting the manufacturer’s prescribing guidelines or ordering through an authorized distributor will help match the correct variant to a patient’s needs.
Are these lenses reusable, or must they be discarded after a single use?
The SOFTACT™ (Deltafilcon A) lenses are intended for single-use/disposable application. The product description explicitly states they are supplied as disposable lenses, meaning they should be discarded after removal, not reused.
What storage conditions should I follow for these lenses before use?
While the provided data does not specify exact storage conditions, as a single-use, non-sterile contact lens, SOFTACT™ (Deltafilcon A) should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The lenses are not pre-sterilized, so they should not be stored in solutions meant for reusable lenses. Always follow the manufacturer’s instructions for optimal handling.