Identity
- Trade Name
- HYPO-CARE STERILE SALINE SPRAY FDA PMA
- Generic Name
- Accessories, soft lens products FDA PMA
Identifiers
- PMA Number
- P860033 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 (Normal 180 Day Track) FDA PMA
The Hypo-Care Sterile Saline Spray is a sterile ophthalmic solution designed for use with soft contact lenses. Classified under Accessories, Soft Lens Products, it is intended to provide saline irrigation or lubrication to maintain lens hygiene and comfort during handling or storage.
Supplied as a single-use, sterile spray bottle, this device is intended for use in ophthalmic settings. It is regulated under FDA PMA (P860033) and falls under the classification of Class II medical devices (LPN). The device is non-reusable and must be stored in a clean, dry environment to preserve sterility.
Frequently asked questions
What is the Hypo-Care Sterile Saline Spray primarily used for in clinical settings?
The Hypo-Care Sterile Saline Spray is designed specifically for use with soft contact lenses to provide saline irrigation or lubrication. It helps maintain lens hygiene and comfort during handling or storage, ensuring a clean and moist environment for the lenses.
Is the Hypo-Care Sterile Saline Spray reusable, or is it intended for single-use only?
The Hypo-Care Sterile Saline Spray is explicitly labeled as a single-use device. After one application, it should not be reused to preserve sterility and prevent contamination.
How should the Hypo-Care Sterile Saline Spray be stored to maintain its sterility?
To maintain sterility, the device must be stored in a clean, dry environment. Avoid exposure to moisture, dust, or direct sunlight, as these conditions could compromise its sterile status.
What regulatory pathway was followed for the approval of the Hypo-Care Sterile Saline Spray?
The Hypo-Care Sterile Saline Spray was approved through the FDA’s Premarket Approval (PMA) process, with the PMA number P860033. It is classified as a Class II medical device under the product code LPN and falls under ophthalmic accessories for soft lens products.
Are there multiple versions or sizes of the Hypo-Care Sterile Saline Spray, or is it supplied in a single standardized form?
The provided data does not specify multiple sizes or versions, but it is supplied as a single-use, sterile spray bottle designed for ophthalmic use with soft contact lenses. The exact variations (if any) would require further product documentation.
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 | P860033 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P860033 23 fields · synced Sep 18, 2026