The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Hercules Model 5000 And 5040 Nd:yag Laser Systems.
| Device ID | K904610 |
| 510k Number | K904610 |
| Device Name: | HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1990-12-19 |