FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Aid, Surgical, Viscoelastic
PMA: P810031
·
Supplement: S081
·
Decision Dec 16, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Aid, Surgical, Viscoelastic
- Trade Name
- Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht
- PMA Number
- P810031
- Supplement Number
- S081
- Device Class
- FDA Class 3
- Product Code
- LZP
- Generic Name
- AID, SURGICAL, VISCOELASTIC
- Regulation Number
- 886.4275
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 16, 2025
- Date Received
- November 26, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
the addition of an alternative supplier of the holder assembly used to deliver the subject ophthalmic viscosurgical devices during surgery
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZP | Aid, Surgical, Viscoelastic | FDA class 3 | Ophthalmic |