FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
PMA: P830062
·
Supplement: S014
·
Decision Aug 30, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
- Trade Name
- ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
- PMA Number
- P830062
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- LOI
- Generic Name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 30, 1989
- Date Received
- April 10, 1989
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- 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 |
|---|---|---|---|
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | FDA class 3 | Unknown |