The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Heraeus Lasersonics Nd:yag Laser, Model 4900.
| Device ID | K882365 |
| 510k Number | K882365 |
| Device Name: | HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 3420 CENTRAL EXPRESSWAY P.O. BOX 58005 Santa Clara, CA 95051 -0793 |
| Contact | Carol Kim |
| Correspondent | Carol Kim 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 | 1988-06-08 |
| Decision Date | 1988-09-02 |