The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Quanta Cyber Tm 150w.
| Device ID | K102749 |
| 510k Number | K102749 |
| Device Name: | QUANTA CYBER TM 150W |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System SpA VIA IV NOVEMBRE, 116 Solbiate Olona, Va, IT 21058 |
| Contact | Isabella Carrer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-09-23 |
| Decision Date | 2010-12-10 |
| Summary: | summary |