Identity
- Trade Name
- THE NORMALINE KIT FDA PMA
- Generic Name
- Accessories, soft lens products FDA PMA
Identifiers
- PMA Number
- P800055 FDA PMA
- FDA Product Code
- LPN FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5928 FDA PMA
- Regulation Number
- 886.5928 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S001 FDA PMA
The Normaline Kit is a soft lens accessory designed for ophthalmic use, classified under Accessories, Soft Lens Products. It is intended to assist in the handling, storage, and maintenance of soft contact lenses, ensuring proper hygiene and care during use.
This device is supplied as a single-use kit and is regulated under FDA Premarket Approval (PMA) with PMA number P800055. It is intended for use in clinical and home settings, adhering to FDA guidelines for ophthalmic accessories. The kit is not MRI-compatible and must be stored in a clean, dry environment as per manufacturer instructions.
Frequently asked questions
Is the Normaline Kit designed for reuse or is it intended for single-use only?
The Normaline Kit is explicitly supplied as a single-use device. This means each kit is intended for one-time use only and should not be reused after opening or exposure to potential contamination. The design ensures proper hygiene and care for soft contact lenses during handling, storage, and maintenance, which is compromised if reused.
What storage conditions are required for the Normaline Kit before use?
The Normaline Kit must be stored in a clean, dry environment as instructed by the manufacturer. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions could degrade the materials or compromise sterility. Proper storage ensures the kit remains effective for its intended single-use application.
Can the Normaline Kit be used in an MRI setting, or does it pose any risks?
The Normaline Kit is not MRI-compatible, meaning it should not be used in or near an MRI machine. The materials or components of the kit could react to the magnetic fields generated during MRI scans, potentially causing safety hazards or interference with the imaging process. Always verify compatibility with the specific MRI system before use.
What regulatory pathway does the Normaline Kit follow, and how does that affect its use?
The Normaline Kit is regulated under the FDA Premarket Approval (PMA) pathway, with PMA number P800055. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use—assisting in the handling, storage, and maintenance of soft contact lenses. Clinicians and users should confirm the kit’s compliance with current FDA guidelines and follow all labeling instructions to ensure proper use in both clinical and home settings.
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 | P800055 | Class II | Active |
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Manufacturer
- Manufacturer
- Apothecary Products, Inc.
Sources (1)
- FDA PMA P800055 24 fields · synced Sep 18, 2026