Wet-N-Soak Rewetting Drops
by Advanced Medical Optics, Inc.
PMA P900047
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP900047 | Date5 Apr 1994 | 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- Withdrawn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
- Full name
- Wet-N-Soak(Tm) Rewetting Drops
- 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
- S002 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Wet-N-Soak Rewetting Drops are a sterile ophthalmic accessory designed for soft contact lenses. Classified under the nomenclature for accessories, soft lens products, these drops are intended to maintain lens hydration and comfort during wear.
Supplied as single-use units, these drops are regulated under FDA PMA (P900047) and fall under device class II. They are intended for use in ophthalmic settings and comply with regulation number 886.5928. Each unit is sterile and packaged for individual application, ensuring proper lens care and maintenance.
Other devices from Advanced Medical Optics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the purpose of Wet-N-Soak Rewetting Drops?
The Wet-N-Soak Rewetting Drops are designed to maintain hydration and comfort for soft contact lenses during wear. They serve as an ophthalmic accessory to enhance lens comfort.
How are the Wet-N-Soak Rewetting Drops supplied?
The drops are supplied as single-use units, each packaged for individual application. This ensures proper lens care and maintenance with each use.
Are the Wet-N-Soak Rewetting Drops sterile?
Yes, each unit of Wet-N-Soak Rewetting Drops is sterile and packaged for individual application to maintain proper hygiene for contact lens users.
What is the regulatory classification of Wet-N-Soak Rewetting Drops?
The drops are classified under device class II and regulated under FDA PMA (P900047), with regulation number 886.5928 for ophthalmic accessories.