FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Identification, Contact Lens
PMA: P820027
·
Supplement: S002
·
Decision Oct 1, 1985
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- System, Identification, Contact Lens
- Trade Name
- SOFTMARK
- PMA Number
- P820027
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- LOH
- Generic Name
- System, identification, contact lens
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 1, 1985
- Date Received
- June 13, 1985
- Expedited Review
- N
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 |
|---|---|---|---|
| LOH | System, Identification, Contact Lens | FDA class 3 | Unknown |