Dynaspray

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Steridyne Dynaspray

Generic Name

Accessories, soft lens products

PMA Number

P860050 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S006 (Normal 180 Day Track)

• Wetting Solution for Hard Contact Lenses

  Class II

  FDA 510(k) K914483 Active Cleared 5 Feb 1992

• Sorbic Acid Preserved Saline Sol.ph Change

  Class II

  FDA PMA P870007 Active Approved 19 Jul 1988

• What is the primary purpose of the Steridyne Dynaspray in clinical or home settings?

  The Steridyne Dynaspray is designed to evenly distribute cleaning, disinfecting, or storage solutions onto soft contact lenses. Its spray mechanism ensures thorough coverage, reducing the need for manual handling and improving efficiency in both clinical and home environments.

• Is the Steridyne Dynaspray intended for single-use or reusable applications?

  The Steridyne Dynaspray is explicitly supplied as a reusable accessory for ophthalmic use. It requires cleaning and maintenance per manufacturer instructions, as it is not sterile at the time of shipment.

• How is the Steridyne Dynaspray regulated by the FDA, and what does that mean for its use?

  The Steridyne Dynaspray is authorized under an FDA PMA (Premarket Approval) with PMA Number P860050, indicating it meets stringent regulatory requirements for safety and effectiveness. This approval covers its classification as an accessory for soft lens products, ensuring compliance with 21 CFR 886.5928—though it does not imply any specific clinical indication beyond its described function.

• Are there different models or variations of the Steridyne Dynaspray, and how might they differ?

  Yes, the Steridyne Dynaspray includes multiple product codes (e.g., LPN) listed in regulatory filings, which likely correspond to variations in design, components, or specifications. These differences may affect functionality (e.g., spray pattern, attachment compatibility) but are not detailed in the provided data.

• What storage or handling considerations should be noted for the Steridyne Dynaspray before first use?

  Since the Steridyne Dynaspray is not sterile at shipment, it must be cleaned and maintained according to the manufacturer’s instructions before use. Proper storage (e.g., dry, protected from contaminants) is critical to ensure hygiene and longevity, especially as it is intended for reusable applications in both clinical and home settings.