FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lenses, Soft Contact, Extended Wear
PMA: P080011
·
Supplement: S186
·
Decision Aug 20, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Lenses, Soft Contact, Extended Wear
- Trade Name
- iWear oxygen presbyopia
- PMA Number
- P080011
- Supplement Number
- S186
- Device Class
- FDA Class 3
- Product Code
- LPM
- Generic Name
- Lenses, soft contact, extended wear
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 20, 2025
- Date Received
- March 14, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
approval for labeling change to add new private label brand name, iWear oxygen presbyopia. The name iWear oxygen presbyopia is intended for the multifocal lens design
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 |
|---|---|---|---|
| LPM | Lenses, Soft Contact, Extended Wear | FDA class 3 | Ophthalmic |