The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for 4000/4900/6000/8000/8900 Yag, & 1700 Yag/co2 Laser.
| Device ID | K881619 |
| 510k Number | K881619 |
| Device Name: | 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 3420 CENTRAL EXPRESSWAY P.O. BOX 58005 Santa Clara, CA 95051 -0793 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath 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 | 1988-04-13 |
| Decision Date | 1988-07-08 |