FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
PMA: P850019
·
Decision Aug 8, 1985
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
- PHOTOTOME(TM) SYSTEM 2700
- PMA Number
- P850019
- 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 8, 1985
- Date Received
- March 28, 1985
- Expedited Review
- N
- Docket Number
- 85M-0391
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 |