FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lens, Intraocular, Phakic
PMA: P030016
·
Supplement: S048
·
Decision Nov 14, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Lens, Intraocular, Phakic
- Trade Name
- VISIAN ICL (IMPLANTABLE COLLAMER LENS)
- PMA Number
- P030016
- Supplement Number
- S048
- Device Class
- FDA Class 3
- Product Code
- MTA
- Generic Name
- Lens, intraocular, phakic
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 14, 2025
- Date Received
- February 14, 2025
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for expanding the indicated age range from 21-45 years old to 21-60 years old for the EVO/EVO+ ICL/TICL.
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 |
|---|---|---|---|
| MTA | Lens, Intraocular, Phakic | FDA class 3 | Unknown |