Guardian 1000
Powered Laser Surgical Instrument
Quanta System SpA
The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Guardian 1000.
Pre-market Notification Details
| Device ID | K151629 |
| 510k Number | K151629 |
| Device Name: | Guardian 1000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System SpA Via IV Novembre, 116 Solbiate Olona (va), IT 21058 |
| Contact | Francesco Dell'antonio |
| Correspondent | Francesco Dell'antonio Quanta System SpA Via IV Novembre, 116 Solbiate Olona (va), IT 21058 |
| Product Code | GEX |
| Subsequent Product Code | ILY |
| Subsequent Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-17 |
| Decision Date | 2015-10-27 |
| Summary: | summary |
Trademark Results [Guardian 1000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUARDIAN 1000 78083854 2563910 Dead/Cancelled |
AIRCELL, LLC 2001-09-13 |
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