87R-SA-TAB
by Amcon, Inc.
PMA P800069
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP800069 | Date31 Jul 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Nor-SA-Tab
- Generic Name
- Accessories, soft lens products
- PMA Number
- FDA Product Code
- LPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S006
Overview
AI-generated summary, 18 Sep 2026
The 87R-SA-TAB is classified as a Soft Lens Product Accessory, designed to assist in the handling, storage, or cleaning of soft contact lenses. It is intended for use in ophthalmic applications, providing a sterile or non-sterile surface for lens care procedures as part of contact lens maintenance routines.
This device is supplied as a reusable accessory, intended for use in clinical or home settings. It is regulated under FDA Premarket Approval (PMA) with PMA number P800069 and falls under product code LPN. Sterility and single-use status are not specified in the data, and no MRI safety information is provided. Storage and handling should follow manufacturer guidelines to maintain integrity.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the 87R-SA-TAB device in contact lens care routines?
The 87R-SA-TAB is designed as a reusable accessory to assist with handling, storage, or cleaning of soft contact lenses. It provides a surface for lens care procedures as part of maintaining contact lenses in both clinical and home settings, ensuring proper hygiene and organization during routine maintenance.
Is the 87R-SA-TAB intended for single-use or repeated use, and how should it be maintained?
The 87R-SA-TAB is explicitly described as a reusable accessory. While the data does not specify sterility requirements, proper cleaning and maintenance per the manufacturer’s guidelines are essential to preserve its integrity and functionality over time.
What regulatory pathway was followed for FDA clearance of the 87R-SA-TAB, and what does this imply for its use?
The 87R-SA-TAB underwent FDA Premarket Approval (PMA) under PMA number P800069, indicating a rigorous review process for its safety and effectiveness. This approval pathway is typically used for higher-risk devices, ensuring compliance with strict regulatory standards before clinical or home use.
Are there specific storage instructions provided for the 87R-SA-TAB, or should it be handled in a particular way?
The data does not detail specific storage conditions, but the manufacturer’s guidelines (not provided here) should be followed to maintain the device’s integrity. Since it is reusable, it should be stored in a clean, dry environment to prevent contamination and ensure longevity.
What distinguishes the 87R-SA-TAB from other soft lens accessories in terms of its regulatory classification?
The 87R-SA-TAB is classified under FDA product code LPN (Lens Products, Non-Prescription) and falls under device class 2, which requires premarket approval due to its role in contact lens care. This classification ensures it meets specific performance and safety standards for reusable accessories in ophthalmic applications.