FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Ultrasound, Cyclodestructive
PMA: P860046
·
Decision Jun 30, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Ultrasound, Cyclodestructive
- Trade Name
- THERAPEUTIC ULTRASOUND FOR TREATMENT OF GLAUCOMA
- PMA Number
- P860046
- Device Class
- FDA Class 2
- Product Code
- LZR
- Generic Name
- Ultrasound, cyclodestructive
- Regulation Number
- 886.5350
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 30, 1988
- Date Received
- October 1, 1986
- Expedited Review
- N
- Docket Number
- 88M-0266
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 |
|---|---|---|---|
| LZR | Ultrasound, Cyclodestructive | FDA class 2 | Ophthalmic |