The following data is part of a premarket notification filed by Incisive Technologies, Inc. with the FDA for Pulsejet Dental Laser System.
| Device ID | K942217 |
| 510k Number | K942217 |
| Device Name: | PULSEJET DENTAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INCISIVE TECHNOLOGIES, INC. 125 SHOREWAY RD. SUITE 3000 San Carlos, CA 94070 |
| Contact | Michael Yessik |
| Correspondent | Michael Yessik INCISIVE TECHNOLOGIES, INC. 125 SHOREWAY RD. SUITE 3000 San Carlos, CA 94070 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-06 |
| Decision Date | 1994-08-03 |