Marlin Squeeze Bottle & Marlin Salt Tablets

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Accessories, soft lens products

PMA Number

P800038 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

• Marlin Contact Lens Case

  Unclassified

  FDA 510(k) K851497 Active Cleared 16 May 1985

• Marlin Soft Lens Handler

  Class I

  FDA 510(k) K850984 Active Cleared 10 Sep 1985

• Marlin Soft Lens Tweezer

  Class I

  FDA 510(k) K850983 Active Cleared 10 Sep 1985

• What is the primary purpose of the Marlin Squeeze Bottle & Marlin Salt Tablets in ophthalmic care?

  The Marlin Squeeze Bottle & Marlin Salt Tablets are designed as an accessory system for soft lens products, specifically to facilitate the storage and handling of contact lens solutions. The squeeze bottle dispenses saline or solution, while the salt tablets dissolve to create a sterile saline solution, ensuring proper lens care and maintenance in ophthalmic settings.

• How should the Marlin Squeeze Bottle & Marlin Salt Tablets be stored and handled?

  Storage and handling of the Marlin Squeeze Bottle & Marlin Salt Tablets must comply with sterile or clean-room protocols, as outlined in FDA guidance under regulation number 886.5928. This ensures the integrity of the system for ophthalmic use, particularly when used for single-use or reusable applications.

• Are the Marlin Squeeze Bottle and Marlin Salt Tablets intended for single-use or reusable applications?

  The Marlin Squeeze Bottle & Marlin Salt Tablets are explicitly designed for both single-use and reusable applications in ophthalmic settings, depending on the clinical workflow and compliance with sterile handling protocols.

• What regulatory pathway was followed for the approval of the Marlin Squeeze Bottle & Marlin Salt Tablets?

  The device received FDA Premarket Approval (PMA) under the designation P800038, indicating it underwent a rigorous review process to ensure safety and effectiveness as an accessory for soft lens products in ophthalmic use.

• How is the Marlin Squeeze Bottle & Marlin Salt Tablets system supplied, and what does it include?

  The system is supplied as a combined unit, consisting of a squeeze bottle for dispensing saline or solution and Marlin Salt Tablets that dissolve to create a sterile saline solution. This integrated approach ensures proper lens care and maintenance for ophthalmic applications.