Sereine Cleaner

No FDA recalls on record, checked 6 Oct 2026.

Generic Name

Accessories, soft lens products

PMA Number

P870050 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• Sereine Wetting & Soaking Solution

  Class II

  CE/MDR FDA PMA P870051 Active Approved 6 Dec 1990

• What is the Sereine Cleaner used for and how does it differ from other contact lens cleaning solutions?

  The Sereine Cleaner is a reusable solution specifically designed for cleaning and maintaining soft contact lenses to ensure proper hygiene. Unlike some single-use solutions, this is intended as a long-term accessory for regular lens care, helping to remove deposits and maintain lens clarity. It is classified under FDA’s Accessories, Soft Lens Products category (LPN) and adheres to ophthalmic use standards outlined in 21 CFR 886.5928.

• Is the Sereine Cleaner intended for single-use or reusable applications, and how should it be stored?

  The Sereine Cleaner is explicitly designed as a reusable solution, not a single-use product. Since it is regulated under FDA Premarket Approval (PMA P870050), proper storage and maintenance are critical to its efficacy and safety. While the data does not specify storage conditions, reusable solutions like this typically require cleaning, disinfection, and proper sealing between uses to prevent contamination.

• Does the Sereine Cleaner come in multiple formulations or sizes, and how can I identify the correct version for my needs?

  Yes, the Sereine Cleaner is available in various formulations and sizes, as indicated by the multiple registration numbers (e.g., 3006140792, 3012236936, etc.) and FEI numbers listed in the data. These variations likely correspond to different pH levels, preservative systems, or other formulations tailored for specific soft lens materials or wear schedules. Always verify the registration number or consult your supplier to ensure compatibility with your lens type.

• What regulatory pathway does the Sereine Cleaner follow, and how does that affect its availability or use?

  The Sereine Cleaner is regulated under FDA Premarket Approval (PMA), with PMA number P870050, indicating it underwent rigorous review by the FDA’s Ophthalmic Devices Advisory Committee (OP). This pathway ensures the solution meets strict safety and effectiveness standards for cleaning soft contact lenses. Availability is governed by FDA compliance, so it must be purchased through authorized distributors or directly from the manufacturer (Trp Company, Reno, NV).

• Are there any known variations or supplements to the original Sereine Cleaner design, and what changes were made?

  Yes, the original Sereine Cleaner has undergone a supplemented approval (Supplement Number S001) under the ‘Normal 180-Day Track’ process. This supplement was filed to account for changes in design, components, specifications, or materials, though the exact modifications are not detailed in the provided data. Such supplements are common when manufacturers update formulations or manufacturing processes to improve performance or safety without altering the core intended use.