The following data is part of a premarket notification filed by Niic U.s.a., Inc. with the FDA for Model Ir107 50-watt Carbon-dioxide Surgical Laser.
| Device ID | K895239 |
| 510k Number | K895239 |
| Device Name: | MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIIC U.S.A., INC. 460 SEAPORT CT., SUITE 101 Redwood City, CA 94063 |
| Contact | Michael Moretti |
| Correspondent | Michael Moretti NIIC U.S.A., INC. 460 SEAPORT CT., SUITE 101 Redwood City, CA 94063 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-21 |
| Decision Date | 1989-11-16 |