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Central's Pharm Salt Tablets for Disinfection

FDA PMA

Class II (US FDA PMA)

PMA P810030

by Central Pharmaceuticals, Inc.

Identity

Trade Name
CENTRAL'S PHARM. SALT TABLETS FOR DISINFECTION FDA PMA
Generic Name
Accessories, soft lens products FDA PMA

Identifiers

PMA Number
P810030 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

This device is classified as Accessories, Soft Lens Products under the nomenclature authority’s classification. It consists of salt tablets designed for disinfection purposes, specifically intended for use with ophthalmic soft contact lenses to ensure proper cleaning and sterilisation.

The tablets are supplied as a single-use product and are regulated under FDA_PMA with approval number P810030. They are intended for use in ophthalmic settings, adhering to regulatory standards outlined in 21 CFR 886.5928. Storage and handling should follow manufacturer guidelines to maintain efficacy.

Frequently asked questions

Are these salt tablets reusable or intended for single-use only?

These tablets are explicitly designed as a single-use product for disinfecting ophthalmic soft contact lenses. Each tablet is meant to be used once and discarded afterward to ensure proper cleaning and sterilization per the manufacturer’s guidelines.

What regulatory pathway was followed for approval of these salt tablets?

The device was approved through the FDA’s Premarket Approval (PMA) process, with approval number P810030. This pathway is typically used for higher-risk medical devices, and the tablets are classified under 21 CFR 886.5928 as accessories for soft lens products.

How should these tablets be stored to maintain their effectiveness?

While the exact storage instructions aren’t detailed in the provided data, the manufacturer’s guidelines (as referenced in the regulatory submission) should be followed to preserve efficacy. Typically, such single-use disinfectant tablets require protection from moisture, extreme temperatures, and contamination until use.

Are there different sizes or models of these salt tablets available?

The provided data does not specify varying sizes or models of the tablets, only that they are supplied as a single-use product for disinfecting soft contact lenses. If multiple formulations or strengths exist, they would likely be differentiated in the product labeling or additional regulatory documentation.

What is the primary purpose of these salt tablets in an ophthalmic setting?

These tablets are specifically intended for disinfecting and sterilizing ophthalmic soft contact lenses. They help ensure proper cleaning by dissolving in water to create a saline solution that removes debris and kills microorganisms, reducing the risk of infection or irritation.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Central Pharmaceuticals, Inc.

Sources (1)

  • FDA PMA P810030 23 fields · synced Sep 18, 2026