The following data is part of a premarket notification filed by Niic U.s.a., Inc. with the FDA for Model 130yz Co2-yag Surgical Laser System.
| Device ID | K880816 |
| 510k Number | K880816 |
| Device Name: | MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NIIC U.S.A., INC. 460 SEAPORT CT., SUITE 101 Redwood City, CA 94063 |
| Contact | Noby H Masuo |
| Correspondent | Noby H Masuo 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 | 1988-02-17 |
| Decision Date | 1988-08-01 |