The following data is part of a premarket notification filed by Ulthera, Inc with the FDA for Ulthera System.
| Device ID | K180623 |
| 510k Number | K180623 |
| Device Name: | Ulthera System |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | Ulthera, Inc 1840 South Stapley Drive Suite 200 Mesa, AZ 85204 |
| Contact | Jessica Newhard |
| Correspondent | Steve Kachelmeyer Ulthera, Inc 1840 South Stapley Drive Suite 200 Mesa, AZ 85204 |
| Product Code | OHV |
| CFR Regulation Number | 878.4590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-09 |
| Decision Date | 2018-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840763101152 | K180623 | 000 |