The following data is part of a premarket notification filed by Alma Lasers, Inc. with the FDA for Alma Lasers Modified Diode Laser Module With Shr Treatment Mode For Use With The Family Of Soprano Xl Multi-application.
| Device ID | K112031 |
| 510k Number | K112031 |
| Device Name: | ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ALMA LASERS, INC. 485 HALF DAY RD. SUITE NO. 100 Buffalo Grove, IL 60089 |
| Contact | Anne Worden |
| Correspondent | Anne Worden ALMA LASERS, INC. 485 HALF DAY RD. SUITE NO. 100 Buffalo Grove, IL 60089 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-15 |
| Decision Date | 2011-09-13 |
| Summary: | summary |