Vis-Sol Sterile Preserved Saline Solution
PMA P870017
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP870017 | Date5 Jul 1990 | 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- Withdrawn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
- Accessories, soft lens products
- PMA Number
- FDA Product Code
- LPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S002 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Vis-Sol Sterile Preserved Saline Solution is classified as an ophthalmic accessory under the nomenclature for soft lens products. It is a sterile, preserved saline solution designed for use with soft contact lenses, providing hydration and maintenance while adhering to ophthalmic standards for lens care.
This solution is supplied in sterile, single-use packaging and is intended for use in ophthalmic settings. It is regulated under FDA Premarket Approval (PMA) with PMA number P870017 and product code LPN, complying with regulation 886.5928. The solution is non-reusable and must be stored according to manufacturer guidelines to maintain sterility and efficacy.
Other devices from Visioncare Assoc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Vis-Sol Sterile Preserved Saline Solution in ophthalmic care?
The Vis-Sol Sterile Preserved Saline Solution is designed specifically for soft contact lens care, providing hydration and maintenance while adhering to ophthalmic standards. It is intended to help preserve lens condition and comfort during storage or handling in clinical settings.
Is this solution reusable, or is it meant for single-use only?
This solution is supplied in sterile, single-use packaging and is explicitly labeled as non-reusable. Each unit is intended for one-time use to maintain sterility and efficacy, aligning with standard ophthalmic practices for lens accessories.
How should the Vis-Sol Sterile Preserved Saline Solution be stored to ensure it remains effective?
The solution must be stored according to the manufacturer’s guidelines to preserve sterility and efficacy. While the exact storage instructions are not detailed here, typical preserved saline solutions require protection from extreme temperatures, contamination, and direct light, often in a cool, dry environment.
What regulatory pathway does this device follow, and what does that mean for its use?
The Vis-Sol Sterile Preserved Saline Solution follows the FDA Premarket Approval (PMA) pathway, with PMA number P870017 and product code LPN. This indicates the device underwent rigorous review by the FDA to ensure safety and effectiveness before market authorization, ensuring it meets strict standards for ophthalmic use.
Are there different sizes or models of this solution available, or is it supplied in a uniform format?
The provided data does not specify distinct sizes or models beyond its classification as a sterile preserved saline solution for soft contact lenses. However, the OpenFDA registration numbers suggest multiple lot or batch identifiers, which may correlate to different packaging sizes or formulations, though exact variations are not detailed in the description.