Identity
- Trade Name
- SOFLENS FDA PMA
- Generic Name
- Lenses, soft contact, extended wear FDA PMA
Identifiers
- PMA Number
- N16895 FDA PMA
- FDA Product Code
- LPM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5925 FDA PMA
- Regulation Number
- 886.5925 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S009 FDA PMA
The SofLens is a Lenses, Soft Contact, Extended Wear device, designed for continuous or prolonged wear in the eye. These lenses are intended to provide extended comfort and vision correction for up to 30 days without removal, as classified under FDA Device Class III (PMA).
These lenses are supplied as single-use or reusable, depending on the specific model, and are regulated under FDA PMA approval (N16895). They are intended for ophthalmic use and must be handled and stored according to manufacturer guidelines to maintain sterility and performance. The device adheres to FDA regulation 886.5925 and is distributed under product code LPM.
Frequently asked questions
Are SofLens contact lenses designed for overnight wear, and if so, how long can they be worn continuously without removal?
Yes, SofLens are classified as **Lenses, Soft Contact, Extended Wear**, meaning they are specifically designed for continuous or prolonged wear in the eye. According to the device description, they are intended for up to **30 days of continuous wear without removal**, providing extended comfort and vision correction during that period.
Are SofLens lenses single-use or reusable, and how should they be handled to maintain sterility?
SofLens lenses are available in **both single-use and reusable models**, depending on the specific variant. To maintain sterility and performance, they must be handled and stored strictly according to the manufacturer’s guidelines, as outlined in the device description. Improper handling could compromise their safety and effectiveness.
What regulatory pathway was followed for SofLens, and what does this mean for clinicians or buyers?
SofLens underwent **FDA Premarket Approval (PMA)** under the classification of **Device Class III**, which is the highest regulatory standard for medical devices. This means the device was thoroughly evaluated for safety and effectiveness before approval, ensuring it meets stringent clinical and performance standards. The PMA number is **N16895**, and it is distributed under product code **LPM**.
Are there different sizes or models of SofLens, and how would a clinician determine the appropriate fit for a patient?
While the provided data does not specify exact sizes or models in detail, the **OpenFDA registration numbers** indicate multiple variants exist under the **generic name
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | N16895 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA N16895 24 fields · synced Sep 18, 2026