The following data is part of a premarket notification filed by Alma Lasers Inc. with the FDA for Alma Lipoflow System.
| Device ID | K171242 |
| 510k Number | K171242 |
| Device Name: | Alma LipoFlow System |
| Classification | System, Suction, Lipoplasty |
| Applicant | Alma Lasers Inc. 485 Half Day Rd, Suite # 100 Buffalo Grove, IL 60089 |
| Contact | Rekha Anand |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-27 |
| Decision Date | 2017-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290110121447 | K171242 | 000 |