Wet-N-Soak
by Advanced Medical Optics, Inc.
PMA P870037
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP870037 | Date5 Jun 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- 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
- S004 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Wet-N-Soak is a soft lens product accessory designed for cleaning and storing soft contact lenses. Classified under the nomenclature for Accessories, Soft Lens Products, it is intended to maintain lens hygiene and integrity between use.
This device is supplied as a reusable solution system for ophthalmic use, with no indication of MRI safety or sterility requirements specified. Multiple product codes (e.g., LPN) and registration numbers (e.g., 3006140792) correspond to various formulations or variants. Authorized under FDA_PMA (PMA Number: P870037), it is regulated under 21 CFR 886.5928 and has undergone labeling updates for shelf life and usage instructions.