The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Aluma Skin Renewal System.
| Device ID | K051214 |
| 510k Number | K051214 |
| Device Name: | ALUMA SKIN RENEWAL SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Contact | Connie Hoy |
| Correspondent | Connie Hoy LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-12 |
| Decision Date | 2005-10-24 |
| Summary: | summary |