The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for Modified Alma Lasers Soprano Xl™ Family Ofmulti-application & Multi-technology Platforms [sopranoxl, Sopranoxli, Sopranoice And Soprano Ice Platinum] With Duo And Trio Diode Laser Modules., Soprano Duo And Trio Diode Laser Modules.
| Device ID | K172193 |
| 510k Number | K172193 |
| Device Name: | Modified Alma Lasers Soprano XL™ Family OfMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE And Soprano ICE Platinum] With Duo And Trio Diode Laser Modules., Soprano Duo And Trio Diode Laser Modules |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Alma Lasers Inc. 485 Half Day Road Suite # 100 Buffalo Grove, IL 60089 |
| Contact | Rekha Anand |
| Correspondent | Rekha Anand Alma Lasers Inc. 485 Half Day Road Suite # 100 Buffalo Grove, IL 60089 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-21 |
| Decision Date | 2018-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121676 | K172193 | 000 |
| 17290110121669 | K172193 | 000 |
| 17290110121652 | K172193 | 000 |
| 17290110121645 | K172193 | 000 |
| 17290110121638 | K172193 | 000 |
| 17290110121621 | K172193 | 000 |
| 17290110123526 | K172193 | 000 |