Unizyme Enzymatic Cleaner
PMA P960024
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP960024 | Date3 Jul 1997 | 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- Withdrawn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
- Unizyme(Tm) Enzymatic Cleaner
- Generic Name
- Accessories, solution, ultrasonic cleaners for lenses
- PMA Number
- FDA Product Code
- LYL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Real-Time Process)
Overview
AI-generated summary, 18 Sep 2026
The Unizyme Enzymatic Cleaner is an enzymatic solution designed for cleaning ophthalmic lenses, classified under accessories for ultrasonic cleaners. It employs enzymatic action to remove protein deposits and debris from contact lenses, maintaining clarity and hygiene for extended wear.
This device is supplied as a sterile solution and is intended for single-use applications in ophthalmic settings. It is regulated under FDA PMA (P960024) and falls under Class II medical devices (device code LYL), with approval for use as a diluent when combined with Ciba Vision’s SOLOCare Multi-Purpose Solution. Storage and handling must comply with manufacturer guidelines to preserve sterility and efficacy.