The following data is part of a premarket notification filed by Niic U.s.a., Inc. with the FDA for Co2 Surgical Laser System Model #ir105.
| Device ID | K882951 |
| 510k Number | K882951 |
| Device Name: | CO2 SURGICAL LASER SYSTEM MODEL #IR105 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIIC U.S.A., INC. 460 SEAPORT CT., SUITE 101 Redwood City, CA 94063 |
| Contact | Jun Nishimura |
| Correspondent | Jun Nishimura 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 | 1988-07-14 |
| Decision Date | 1988-11-02 |