The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for (hli) Carbon Dioxide Systems W/infraguide Co2.
| Device ID | K885181 |
| 510k Number | K885181 |
| Device Name: | (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 3420 CENTRAL EXPRESSWAY P.O. BOX 58005 Santa Clara, CA 95051 -0793 |
| Contact | Donna Page |
| Correspondent | Donna Page HERAEUS LASERSONICS, INC. 3420 CENTRAL EXPRESSWAY P.O. BOX 58005 Santa Clara, CA 95051 -0793 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-14 |
| Decision Date | 1989-01-10 |