MICRO YAG ND:YAG LASER SYSTEM
FDA premarket approval P850063 · decided 1986-01-31
Approval details
- PMA number
- P850063
- Trade name
- MICRO YAG ND:YAG LASER SYSTEM
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- Sorin Group USA, Inc.
- Date received
- 1985-09-03
- Decision date
- 1986-01-31
- Days to decision
- 150 days
- Decision code
- APWD
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Arvada, CO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 (K122735) | Sorin Group USA, Inc. | 2013-05-21 |
| VASCUCLEAR PRECISION BIPOLAR (K102983) | Sorin Group USA, Inc. | 2010-11-01 |