The following data is part of a premarket notification filed by Lumenis with the FDA for Lumenis Family Of Ipl And Combination Ipl/nd:yag Systems.
| Device ID | K030527 |
| 510k Number | K030527 |
| Device Name: | LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS 2400 CONDENSA ST. Santa Clara, CA 95051 |
| Contact | Andrea L Ruth |
| Correspondent | Andrea L Ruth LUMENIS 2400 CONDENSA ST. Santa Clara, CA 95051 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-05-20 |
| Summary: | summary |