The following data is part of a premarket notification filed by Pfizer Laser Systems with the FDA for Orion Yag Laser System Ear, Nose, & Throat Applic..
| Device ID | K910825 |
| 510k Number | K910825 |
| Device Name: | ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC. |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
| Contact | Colette Cozean |
| Correspondent | Colette Cozean PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1993-02-26 |