Softics (Polymacon) Lenses
PMA P830012
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830012 | Date29 Aug 1988 | 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- Withdrawn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
- Full name
- Softics(Tm) (Polymacon)
- 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
- S003 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Softics (Polymacon) Lenses are classified as Lenses, Soft Contact, Daily Wear, designed for corneal or scleral fitting to correct refractive errors or manage ocular conditions. These lenses are made from polymacon, a silicone hydrogel material, providing clear vision with optimal oxygen permeability for extended daily wear.
These lenses are intended for ophthalmic use and are supplied as single-use or reusable depending on the specific prescription. They are regulated under FDA Premarket Approval (PMA) with the designation P830012 and fall under device class II (OpenFDA: LPL). Sterility and packaging details are not specified but must comply with FDA regulations for contact lenses, including 886.5925. Storage conditions and MRI safety are not documented in the provided data.
Questions
AI-generated answers, 18 Sep 2026
Are these lenses designed for extended wear, or are they only meant for daily use?
The Softics™ (Polymacon) lenses are classified as daily wear contact lenses, meaning they are intended for wear during the daytime only, not for continuous overnight use. While they are made from a silicone hydrogel material (polymacon) that provides optimal oxygen permeability, this does not extend their wear schedule beyond the standard daily wear designation.
How are these lenses supplied—are they single-use or reusable, and how does that affect my ordering decisions?
The Softics™ (Polymacon) lenses are supplied in both single-use and reusable formats, depending on the specific prescription. Single-use lenses are designed for one-time wear and disposal, while reusable lenses are intended for multiple wears with proper cleaning and maintenance. This flexibility allows clinicians to choose based on patient needs, hygiene preferences, and compliance.
What should I consider when storing these lenses, and are there any specific conditions mentioned in the data?
The provided data does not explicitly detail storage conditions for the Softics™ (Polymacon) lenses, but as contact lenses regulated under FDA 886.5925, they must comply with general industry standards for cleanliness, humidity, and temperature control. Typically, lenses should be stored in a clean, dry case away from direct sunlight and extreme temperatures. Always follow the manufacturer’s (Ideal Optics, Inc.) specific storage instructions included with the packaging.
What regulatory pathway does this device follow, and how does that impact its availability or approval status?
The Softics™ (Polymacon) lenses are regulated under FDA Premarket Approval (PMA) with the designation P830012, indicating they fall under Class II devices (OpenFDA: LPL). This means the device has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use—correcting refractive errors or managing ocular conditions via corneal or scleral fitting. Availability is governed by this approval, and clinicians should confirm with their local distributors or Ideal Optics, Inc. for stock and ordering details.