Armsof Soft Contact Lenses
by Lombart Optical of Virginia, Ltd.
PMA N18018
Active
Valid until
No expiry
FDA recalls
None foundDocuments
PMA N18018
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN18018 | Date21 May 1980 | 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- Withdrawn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
- Armsof Soft Contact Lense
- 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
Overview
AI-generated summary, 18 Sep 2026
The Armsof Soft Contact Lenses are classified as Lenses, Soft Contact, Daily Wear, designed for corneal or scleral contact lens applications. These devices are intended to correct refractive errors or improve vision by resting directly on the eye’s surface, providing clear and comfortable vision for daily use.
These lenses are supplied as single-use or disposable products, intended for use in ophthalmic settings. Authorized under FDA_PMA with PMA number N18018, they are regulated as Class II medical devices under 21 CFR 886.5925. Multiple registration numbers and product codes (e.g., LPL) identify specific variants, though exact sizes or material specifications are not detailed in the provided data.
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses designed for extended wear, or are they meant for daily use only?
The Armsof Soft Contact Lenses are explicitly classified as *daily wear* devices, meaning they are intended for use during waking hours only and are not designed for overnight or extended wear. This classification aligns with their primary purpose of correcting refractive errors or improving vision while providing comfort for daily activities.
How are these lenses supplied, and are they single-use or reusable?
The Armsof Soft Contact Lenses are supplied as *single-use or disposable* products, as indicated by their classification and intended use in ophthalmic settings. This means each lens is intended for one-time use and should not be reused, reducing the risk of infection or irritation.
What regulatory pathway was followed for approval of these contact lenses?
The Armsof Soft Contact Lenses were authorized under the FDA Pre-Market Approval (PMA) process, with PMA number N18018. This pathway is typically required for higher-risk medical devices, including certain contact lenses, to ensure safety and effectiveness before market authorization. The device is classified as a Class II medical device under 21 CFR 886.5925.
Are there multiple sizes or models available for these lenses, and how would I identify them?
While the provided data lists numerous registration numbers and FEI codes (e.g., 3015533540, 3012546757), it does not specify exact sizes, materials, or model variations beyond the general classification as *soft contact lenses for corneal or scleral use*. To determine the correct size or model for a patient, you would need to consult the manufacturer’s catalog or documentation, as these details are not explicitly outlined in the regulatory submission.