The following data is part of a premarket notification filed by Leisegang Medical, Inc. with the FDA for Smoothlase Alexandrite Laser System.
| Device ID | K990043 |
| 510k Number | K990043 |
| Device Name: | SMOOTHLASE ALEXANDRITE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-06 |
| Decision Date | 1999-02-11 |
| Summary: | summary |