The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for Modified Alma Lasers Soprano Xl Family Of Multi-application & Multi-technology Platform, Soprano Yag Hand Piece.
| Device ID | K170626 |
| 510k Number | K170626 |
| Device Name: | Modified Alma Lasers Soprano XL Family Of Multi-Application & Multi-Technology Platform, Soprano YAG Hand Piece |
| 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 | 2017-03-02 |
| Decision Date | 2017-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121416 | K170626 | 000 |