The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Laser-shield Ii(tm).
| Device ID | K901016 |
| 510k Number | K901016 |
| Device Name: | LASER-SHIELD II(TM) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Contact | Donald R Bruce |
| Correspondent | Donald R Bruce XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 -0980 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-05 |
| Decision Date | 1990-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490156080 | K901016 | 000 |
| 00681490156073 | K901016 | 000 |
| 00681490156066 | K901016 | 000 |
| 00681490156059 | K901016 | 000 |
| 00681490156042 | K901016 | 000 |
| 00681490156035 | K901016 | 000 |
| 00681490156028 | K901016 | 000 |
| 00681490156011 | K901016 | 000 |
| 00681490155946 | K901016 | 000 |